array(40) {
  ["request_overridden_res"]=>
  string(1) "3"
  ["project_status"]=>
  string(30) "approved_pending_dua_signature"
  ["project_assoc_trials"]=>
  array(5) {
    [0]=>
    object(WP_Post)#5598 (24) {
      ["ID"]=>
      int(13163)
      ["post_author"]=>
      string(4) "1363"
      ["post_date"]=>
      string(19) "2023-08-09 22:12:42"
      ["post_date_gmt"]=>
      string(19) "2023-08-09 22:12:42"
      ["post_content"]=>
      string(0) ""
      ["post_title"]=>
      string(258) "NCT02407236 - A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis"
      ["post_excerpt"]=>
      string(0) ""
      ["post_status"]=>
      string(7) "publish"
      ["comment_status"]=>
      string(6) "closed"
      ["ping_status"]=>
      string(6) "closed"
      ["post_password"]=>
      string(0) ""
      ["post_name"]=>
      string(193) "nct02407236-a-phase-3-randomized-double-blind-placebo-controlled-parallel-group-multicenter-protocol-to-evaluate-the-safety-and-efficacy-of-ustekinumab-induction-and-maintenance-therapy-in-subj"
      ["to_ping"]=>
      string(0) ""
      ["pinged"]=>
      string(0) ""
      ["post_modified"]=>
      string(19) "2025-05-15 16:28:46"
      ["post_modified_gmt"]=>
      string(19) "2025-05-15 20:28:46"
      ["post_content_filtered"]=>
      string(0) ""
      ["post_parent"]=>
      int(0)
      ["guid"]=>
      string(242) "https://dev-yoda.pantheonsite.io/clinical-trial/nct02407236-a-phase-3-randomized-double-blind-placebo-controlled-parallel-group-multicenter-protocol-to-evaluate-the-safety-and-efficacy-of-ustekinumab-induction-and-maintenance-therapy-in-subj/"
      ["menu_order"]=>
      int(0)
      ["post_type"]=>
      string(14) "clinical_trial"
      ["post_mime_type"]=>
      string(0) ""
      ["comment_count"]=>
      string(1) "0"
      ["filter"]=>
      string(3) "raw"
    }
    [1]=>
    object(WP_Post)#5599 (24) {
      ["ID"]=>
      int(1688)
      ["post_author"]=>
      string(4) "1363"
      ["post_date"]=>
      string(19) "2018-06-07 11:30:00"
      ["post_date_gmt"]=>
      string(19) "2018-06-07 11:30:00"
      ["post_content"]=>
      string(0) ""
      ["post_title"]=>
      string(251) "NCT00488774 - A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis"
      ["post_excerpt"]=>
      string(0) ""
      ["post_status"]=>
      string(7) "publish"
      ["comment_status"]=>
      string(6) "closed"
      ["ping_status"]=>
      string(6) "closed"
      ["post_password"]=>
      string(0) ""
      ["post_name"]=>
      string(193) "nct00488774-a-phase-2-3-multicenter-randomized-placebo-controlled-double-blind-study-to-evaluate-the-safety-and-efficacy-of-golimumab-induction-therapy-administered-intravenously-in-subjects-wi"
      ["to_ping"]=>
      string(0) ""
      ["pinged"]=>
      string(0) ""
      ["post_modified"]=>
      string(19) "2025-10-28 13:37:56"
      ["post_modified_gmt"]=>
      string(19) "2025-10-28 17:37:56"
      ["post_content_filtered"]=>
      string(0) ""
      ["post_parent"]=>
      int(0)
      ["guid"]=>
      string(242) "https://dev-yoda.pantheonsite.io/clinical-trial/nct00488774-a-phase-2-3-multicenter-randomized-placebo-controlled-double-blind-study-to-evaluate-the-safety-and-efficacy-of-golimumab-induction-therapy-administered-intravenously-in-subjects-wi/"
      ["menu_order"]=>
      int(0)
      ["post_type"]=>
      string(14) "clinical_trial"
      ["post_mime_type"]=>
      string(0) ""
      ["comment_count"]=>
      string(1) "0"
      ["filter"]=>
      string(3) "raw"
    }
    [2]=>
    object(WP_Post)#5600 (24) {
      ["ID"]=>
      int(1583)
      ["post_author"]=>
      string(4) "1363"
      ["post_date"]=>
      string(19) "2017-01-04 14:53:00"
      ["post_date_gmt"]=>
      string(19) "2017-01-04 14:53:00"
      ["post_content"]=>
      string(0) ""
      ["post_title"]=>
      string(252) "NCT00488631 - A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis"
      ["post_excerpt"]=>
      string(0) ""
      ["post_status"]=>
      string(7) "publish"
      ["comment_status"]=>
      string(6) "closed"
      ["ping_status"]=>
      string(6) "closed"
      ["post_password"]=>
      string(0) ""
      ["post_name"]=>
      string(193) "nct00488631-a-phase-3-multicenter-randomized-placebo-controlled-double-blind-study-to-evaluate-the-safety-and-efficacy-of-golimumab-maintenance-therapy-administered-subcutaneously-in-subjects-w"
      ["to_ping"]=>
      string(0) ""
      ["pinged"]=>
      string(0) ""
      ["post_modified"]=>
      string(19) "2025-10-28 13:37:20"
      ["post_modified_gmt"]=>
      string(19) "2025-10-28 17:37:20"
      ["post_content_filtered"]=>
      string(0) ""
      ["post_parent"]=>
      int(0)
      ["guid"]=>
      string(242) "https://dev-yoda.pantheonsite.io/clinical-trial/nct00488631-a-phase-3-multicenter-randomized-placebo-controlled-double-blind-study-to-evaluate-the-safety-and-efficacy-of-golimumab-maintenance-therapy-administered-subcutaneously-in-subjects-w/"
      ["menu_order"]=>
      int(0)
      ["post_type"]=>
      string(14) "clinical_trial"
      ["post_mime_type"]=>
      string(0) ""
      ["comment_count"]=>
      string(1) "0"
      ["filter"]=>
      string(3) "raw"
    }
    [3]=>
    object(WP_Post)#5601 (24) {
      ["ID"]=>
      int(1144)
      ["post_author"]=>
      string(4) "1363"
      ["post_date"]=>
      string(19) "2014-09-22 11:06:00"
      ["post_date_gmt"]=>
      string(19) "2014-09-22 11:06:00"
      ["post_content"]=>
      string(0) ""
      ["post_title"]=>
      string(252) "NCT00487539 - A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis"
      ["post_excerpt"]=>
      string(0) ""
      ["post_status"]=>
      string(7) "publish"
      ["comment_status"]=>
      string(6) "closed"
      ["ping_status"]=>
      string(6) "closed"
      ["post_password"]=>
      string(0) ""
      ["post_name"]=>
      string(193) "nct00487539-a-phase-2-3-multicenter-randomized-placebo-controlled-double-blind-study-to-evaluate-the-safety-and-efficacy-of-golimumab-induction-therapy-administered-subcutaneously-in-subjects-w"
      ["to_ping"]=>
      string(0) ""
      ["pinged"]=>
      string(0) ""
      ["post_modified"]=>
      string(19) "2025-10-28 13:33:21"
      ["post_modified_gmt"]=>
      string(19) "2025-10-28 17:33:21"
      ["post_content_filtered"]=>
      string(0) ""
      ["post_parent"]=>
      int(0)
      ["guid"]=>
      string(242) "https://dev-yoda.pantheonsite.io/clinical-trial/nct00487539-a-phase-2-3-multicenter-randomized-placebo-controlled-double-blind-study-to-evaluate-the-safety-and-efficacy-of-golimumab-induction-therapy-administered-subcutaneously-in-subjects-w/"
      ["menu_order"]=>
      int(0)
      ["post_type"]=>
      string(14) "clinical_trial"
      ["post_mime_type"]=>
      string(0) ""
      ["comment_count"]=>
      string(1) "0"
      ["filter"]=>
      string(3) "raw"
    }
    [4]=>
    object(WP_Post)#5602 (24) {
      ["ID"]=>
      int(1114)
      ["post_author"]=>
      string(4) "1363"
      ["post_date"]=>
      string(19) "2014-09-22 10:31:00"
      ["post_date_gmt"]=>
      string(19) "2014-09-22 10:31:00"
      ["post_content"]=>
      string(0) ""
      ["post_title"]=>
      string(159) "NCT00036439 - A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis"
      ["post_excerpt"]=>
      string(0) ""
      ["post_status"]=>
      string(7) "publish"
      ["comment_status"]=>
      string(6) "closed"
      ["ping_status"]=>
      string(6) "closed"
      ["post_password"]=>
      string(0) ""
      ["post_name"]=>
      string(155) "nct00036439-a-randomized-placebo-controlled-double-blind-trial-to-evaluate-the-safety-and-efficacy-of-infliximab-in-patients-with-active-ulcerative-colitis"
      ["to_ping"]=>
      string(0) ""
      ["pinged"]=>
      string(0) ""
      ["post_modified"]=>
      string(19) "2025-07-30 10:12:17"
      ["post_modified_gmt"]=>
      string(19) "2025-07-30 14:12:17"
      ["post_content_filtered"]=>
      string(0) ""
      ["post_parent"]=>
      int(0)
      ["guid"]=>
      string(204) "https://dev-yoda.pantheonsite.io/clinical-trial/nct00036439-a-randomized-placebo-controlled-double-blind-trial-to-evaluate-the-safety-and-efficacy-of-infliximab-in-patients-with-active-ulcerative-colitis/"
      ["menu_order"]=>
      int(0)
      ["post_type"]=>
      string(14) "clinical_trial"
      ["post_mime_type"]=>
      string(0) ""
      ["comment_count"]=>
      string(1) "0"
      ["filter"]=>
      string(3) "raw"
    }
  }
  ["project_title"]=>
  string(85) "The Patient Profile and Predictors of Asymptomatic Inflammation in Ulcerative Colitis"
  ["project_narrative_summary"]=>
  string(860) "The treatment goals of ulcerative colitis (UC) must target both symptomatic control and endoscopic remission. However, symptom control does not necessarily reflect endoscopic remission. This highlights two clinically distinct states among asymptomatic patients: “Asymptomatic Inflammation”, characterized by the absence of symptoms despite active endoscopic inflammation, and “Asymptomatic Remission”, where patients achieve both symptomatic and endoscopic remission.



This study aims to characterize the clinical profile of patients with asymptomatic inflammation and delineate the risk factors associated with asymptomatic inflammation. We will perform pooled analyses on data from 14 clinical trials including UC patients. Our findings are expected to provide a clearer understanding of asymptomatic inflammation in UC.



"
  ["project_learn_source"]=>
  string(9) "colleague"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(6) "Sun-Ho"
    ["last_name"]=>
    string(3) "Lee"
    ["degree"]=>
    string(3) "PhD"
    ["primary_affiliation"]=>
    string(20) "Mount Sinai Hospital"
    ["email"]=>
    string(25) "Sun-Ho.Lee@sinaihealth.ca"
    ["state_or_province"]=>
    string(7) "Ontario"
    ["country"]=>
    string(6) "Canada"
  }
  ["project_key_personnel"]=>
  array(1) {
    [0]=>
    array(6) {
      ["p_pers_f_name"]=>
      string(6) "Rirong"
      ["p_pers_l_name"]=>
      string(4) "Chen"
      ["p_pers_degree"]=>
      string(4) "M.D."
      ["p_pers_pr_affil"]=>
      string(20) "Mount Sinai Hospital"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
    }
  }
  ["project_ext_grants"]=>
  array(2) {
    ["value"]=>
    string(2) "no"
    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
  }
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1611) "Background: Approximately 70% of UC patients with symptomatic control failed to achieve endoscopic remission after induction therapy, reflecting an asymptomatic inflammation status. Given that these patients lack overt symptoms, their ongoing inflammatory activity is frequently overlooked in clinical practice. Therefore, characterizing the clinical profile and predictors of asymptomatic inflammation will enable better patient stratification.



Objective: To characterize the clinical profile of patients with asymptomatic inflammation and delineate the risk factors associated with asymptomatic inflammation.

Study Design: This is a pooled analysis integrating 14 clinical trials that assessed clinical, endoscopic or histological outcomes in patients with UC.  



Participants: Our study cohort comprised patients with moderate to severe active UC from 14 trials. The primary predictors are demographic factors, clinical factors, and biomarkers. 



Primary and Secondary Outcome Measure(s) : The study outcomes include asymptomatic inflammation (achieving asymptomatic status without endoscopic remission), and asymptomatic remission (achieving both asymptomatic status and endoscopic remission) at the end of induction as well as maintenance therapy.



Statistical Analysis: For each individual trial, multivariable regression will be performed to calculate adjusted odds ratios and corresponding 95% confidence intervals (CI), separately. Adjusted odds ratios and 95% CI will be combined using a DerSimonian--Laird random-effects meta-analysis. "
  ["project_brief_bg"]=>
  string(3120) "Ulcerative colitis (UC), a type of inflammatory bowel disease, is characterized by recurrent inflammation of the colon and rectum. Common clinical manifestations of UC include rectal bleeding and increased stool frequency, with endoscopic findings typically showing mucosal erythema and ulceration (1). Currently, millions of people worldwide are affected by UC, and the number of patients with UC continues to increase globally (2). Furthermore, patients with UC will suffer from a relapsing-remitting course, an elevated risk of colorectal carcinoma, and impaired quality of life. To improve disease prognosis and quality of life, the Selecting Therapeutic Targets in Inflammatory Bowel Disease II (STRIDE-II) guidelines mandate that treatment goals must target both symptomatic control (defined as the absence of rectal bleeding and normal stool frequency) and endoscopic remission (resolution of mucosal inflammation assessed by colonoscopy) (3). 



With current advanced therapies for UC including biologics and small-molecule agents, approximately 30%-50% of patients achieve symptomatic control (4, 5). While symptom relief significantly improves quality of life, it does not necessarily reflect mucosal healing. Evidence suggests a significant discordance between clinical symptoms and endoscopic findings in UC (6). A previous study showed that approximately 70% of UC patients with symptomatic control failed to achieve endoscopic remission after induction therapy, and 40% exhibited persistent endoscopic activity after maintenance therapy (7). This highlights two clinically distinct states among asymptomatic patients: “Asymptomatic Inflammation”, characterized by the absence of symptoms despite active endoscopic inflammation, and “Asymptomatic Remission”, where patients achieve both symptomatic control and endoscopic remission.



Critically, post hoc analyses of previous studies have demonstrated that patients with asymptomatic inflammation face a significantly higher risk of clinical relapse and poor prognosis, compared to those with asymptomatic remission (8). However, the clinical profile of this subgroup is poorly characterized, and the predictors associated with fail to achieve asymptomatic remission remain unclear. Given that these patients lack overt symptoms, their ongoing inflammatory activity is frequently overlooked in clinical practice. Therefore, characterizing the clinical profile and predictors of asymptomatic inflammation will enable better patient stratification. This allows for intensified surveillance of at-risk individuals and supports the implementation of tailored management approaches.



This study aims to characterize the clinical profile of patients with asymptomatic inflammation, and delineate the risk factors associated with asymptomatic inflammation, compared with asymptomatic remission. Furthermore, we will evaluate the ability of existing biomarkers in distinguishing asymptomatic inflammation from asymptomatic remission, with the ultimate goal of reducing the reliance on repeated colonoscopies.

"
  ["project_specific_aims"]=>
  string(748) "This study aims at investigating the clinical profile and predictors of patients with asymptomatic inflammation. 



Aim 1: Clarify the risk factors of asymptomatic inflammation, compared with asymptomatic remission.

Hypothesis 1: Specific demographic, clinical, and biomarker factors are significantly associated with the presence of asymptomatic inflammation when compared with asymptomatic remission.



Aim 2: Evaluate the ability of existing non-invasive biomarkers to distinguish asymptomatic inflammation from asymptomatic remission.

Hypothesis 2: The existing biomarkers (e.g. fecal calprotectin, C-reactive protein) could help distinguish asymptomatic inflammation from asymptomatic remission.

"
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(14) "indiv_trial_an"
    ["label"]=>
    string(25) "Individual trial analysis"
  }
  ["project_purposes"]=>
  array(3) {
    [0]=>
    array(2) {
      ["value"]=>
      string(56) "new_research_question_to_examine_treatment_effectiveness"
      ["label"]=>
      string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(22) "participant_level_data"
      ["label"]=>
      string(36) "Participant-level data meta-analysis"
    }
    [2]=>
    array(2) {
      ["value"]=>
      string(56) "participant_level_data_meta_analysis_from_yoda_and_other"
      ["label"]=>
      string(69) "Meta-analysis using data from the YODA Project and other data sources"
    }
  }
  ["project_research_methods"]=>
  string(859) "This is a pooled analysis integrating clinical trials that assessed clinical, endoscopic or histological outcomes in patients with UC, such as UNIFI (NCT02407236), PURSUIT (NCT00487539, NCT00488774, NCT00488631), VARSITY (NCT02497469), GEMINI-1 (NCT00783718), SELECTION (NCT02914522), U-ACHIEVE (NCT02819635), LUCENT-1 (NCT03518086), LUCENT-2 (NCT03524092), OCTAVE-1 (NCT01465763), OCTAVE-2 (NCT01458574), ULTRA-2 (NCT00408629), SERENE (NCT02065622), ACT-1 (NCT00036439) and GEMINI-LTS (NCT00790933). All the data will be obtained through Vivli and YODA. Our study cohort comprised patients with moderate to severe active UC from these trials. Exclusion criteria included the absence of symptomatic activity assessment (e.g., Mayo score) and endoscopic activity assessment (e.g., Mayo endoscopic score or UCEIS) at the end of induction or maintenance therapy."
  ["project_main_outcome_measure"]=>
  string(860) "The primary outcomes are asymptomatic inflammation versus asymptomatic remission post-induction (at 8-12 weeks) and at 52 weeks.



Asymptomatic inflammation: defined by both asymptomatic status and endoscopic inflammation. 

Asymptomatic status is defined as Mayo rectal bleeding subscore = 0 and Mayo stool frequency subscore = 0. 

Endoscopic inflammation is defined as Mayo endoscopic subscore > 0.

Asymptomatic remission: Patients with asymptomatic status, while none endoscopic inflammation. 



Secondary Outcome Measures

Exploratory analyses of the subgroups, using incorporated endpoints of both asymptomatic status (Mayo rectal bleeding subscore = 0 and Mayo stool frequency subscore = 0) and histological inflammation (Geboes score > 2) at the end of induction and maintenance therapy.

"
  ["project_main_predictor_indep"]=>
  string(987) "Potential predictors of treatment response were selected a priori based on biological plausibility and previously established clinical covariates. These will be included to characterize the study sample and adjust for potential confounders in multivariable models. The candidate variables encompassed the following domains: 



Disease Characteristics: 

Disease duration: the length of time between the initial diagnosis and the date of trial enrolment

Disease extent: limited vs extensive 

Presence of extraintestinal manifestations: yes vs no

Baseline disease activity, assessed by Mayo score

Baseline histological characteristics, assessed by Geboes score



Medication history:

Concomitant corticosteroid or immunomodulator use: yes vs no

Prior exposure to biologics: biologic-naïve vs biologic-experienced



Biochemical markers 

Fecal calprotectin, C-reactive protein and Albumin.

"
  ["project_other_variables_interest"]=>
  string(126) "Demographics: 

Age at baseline: continuous (years) 

Sex: male vs female

Current smoking status: yes vs no"
  ["project_stat_analysis_plan"]=>
  string(3625) "The primary objective is to investigate the clinical profile and risk factors of asymptomatic inflammation. Analyses will follow a pre-specified plan to ensure transparency and reproducibility, using harmonized definitions across trials. Analyses will be performed in R (version >= 4.3.0), with two-sided < 0.05 considered statistically significant unless adjusted for multiple testing.



1. Descriptive Analyses

Baseline demographic and clinical characteristics will be summarized according to groups at the end of induction and maintenance therapy. Continuous variables will be expressed as median (interquartile range) or mean (standard deviation) depending on distribution.

Categorical variables will be summarized as counts and percentages. 

Group comparisons: Kruskal-Wallis test with dunn post hoc tests for continuous variables; Chi-square or Fisher's exact test for categorical variables.



2. Pooled Analysis of Patient-Level Data

To ensure dataset completeness, this analysis will pool individual patient data at the trial level and performed a unified recalibration of all endpoint measures. Furthermore, the meta-analytic model will incorporate "study" as a random effect, inherently accounting for between-study variation. The study identifier of individuals will also be preserved throughout the analysis to maintain the structure and the independence of the studies. 



3. Primary Analyses (Predictors of patients with asymptomatic inflammation)

For each individual trial, multivariable regression will be performed to calculate adjusted odds ratios and corresponding 95% confidence intervals (CI), separately. The confounders adjusted in the multivariable logistic model include: age, sex, baseline disease activity, prior biologic exposure, treatment allocation, and concomitant corticosteroid or immunomodulator use.



4. Meta-Analysis Across Trials

Adjusted odds ratios and 95% CI will be extracted for each trial and combined using a DerSimonian--Laird random-effects meta-analysis. Heterogeneity will be assessed with Cochran's Q test and quantified using the I^2 statistic.



5. Secondary and Exploratory Analyses

Subgroup Analyses: Further stratified asymptomatic inflammation or asymptomatic remission groups according to whether histological inflammation.

Sensitivity Analyses: Use an alternative, expanded definition for clinical remission: rectal bleeding subscore = 0 and stool frequency subscore = 0 or 1 to confirm the robustness of the results.



6. Missing Data

Patients missing the definite group data will be excluded.

To handle missing data in other covariates, we will employ multiple imputation by chained equations (MICE), under the assumption that data are missing at random. Ten imputed datasets will be created, and the results will subsequently be pooled using Rubin’s rules for final inference.



7. Assessment of predictors

Receiver operating characteristic (ROC) curve analyses were conducted, and the area under the ROC curve (AUC) values with 95 % confidence intervals were computed to evaluate the diagnostic accuracy of potential predictors of asymptomatic inflammation. Otherwise, sensitivity, specificity, positive predictive value, and negative predictive value for each potential predictor are also calculated and presented as percentages.



8. Reporting

Results will be primarily presented as overall adjusted ORs (95% CIs) for binomial outcomes.

"
  ["project_software_used"]=>
  array(1) {
    [0]=>
    array(2) {
      ["value"]=>
      string(7) "rstudio"
      ["label"]=>
      string(7) "RStudio"
    }
  }
  ["project_timeline"]=>
  string(699) "Project start date: June 20, 2026 

Key milestones: 12 months time window

- Jun--Aug 2026: Data receipt, trial inventory confirmation, variable mapping/harmonization, analysis-ready dataset.

- Sep--Dec 2026: Primary one-stage IPD models, prespecified interaction testing, initial tables/figures.

- Jan--Mar 2027: Sensitivity analyses, finalize results.

- Analysis completion date: June 20, 2027.

- Manuscript drafted: May 2027.

- First journal submission: June 2027.

- Results reported back to YODA: within 30 days of analysis completion (target: July 2027), including summary of outputs/publication status per DUA expectations.



"
  ["project_dissemination_plan"]=>
  string(1424) "The results of this study will be widely disseminated to ensure maximal scientific and clinical impact. The main output will be a manuscript investigating the clinical profile of patients with asymptomatic inflammation, which will be submitted to high-impact, peer-reviewed journals such as Gastroenterology, Gut, or Clinical Gastroenterology and Hepatology. If warranted, a secondary manuscript may be prepared to compare long-term outcomes of three groups defined in this study.



Findings will also be presented at major international conferences, including Digestive Disease Week (DDW), the European Crohn’s and Colitis Organization (ECCO) Congress, and other relevant gastroenterology meetings. Clinician-focused summaries will be shared through professional workshops, institutional grand rounds, and specialty networks.



The target audiences comprise gastroenterologists, clinical trial investigators, translational researchers, guideline committees, and health policy makers. By clarifying the clinical profile of patients with asymptomatic inflammation, this study may help refine treat-to-target approaches, improve clinical trial design, and support earlier treatment interventions in this easily overlooked population.



All publications and presentations resulting from this work will include acknowledgements to the Vivli Project platform and the YODA Project.

"
  ["project_bibliography"]=>
  string(1610) "

Le Berre C, Honap S, Peyrin-Biroulet L. Ulcerative colitis. LANCET. 2023;402(10401):571-84.
Hracs L, Windsor JW, Gorospe J, Cummings M, Coward S, Buie MJ, et al. Global evolution of inflammatory bowel disease across epidemiologic stages. NATURE. 2025;642(8067):458-66.
Turner D, Ricciuto A, Lewis A, D’Amico F, Dhaliwal J, Griffiths AM, et al. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. GASTROENTEROLOGY. 2021;160(5):1570-83.
Gros B, Kaplan GG. Ulcerative Colitis in Adults: A Review. JAMA. 2023;330(10):951-65.
Baumgart DC, Le Berre C. Newer Biologic and Small-Molecule Therapies for Inflammatory Bowel Disease. N Engl J Med. 2021;385(14):1302-15.
Colombel JF, Keir ME, Scherl A, Zhao R, de Hertogh G, Faubion WA, et al. Discrepancies between patient-reported outcomes, and endoscopic and histological appearance in UC. GUT. 2017;66(12):2063-8.
Dulai PS, Singh S, Jairath V, Ma C, Narula N, Vande Casteele N, et al. Prevalence of endoscopic improvement and remission according to patient-reported outcomes in ulcerative colitis. Aliment Pharmacol Ther. 2020;51(4):435-45.
Yoon H, Jangi S, Dulai PS, Boland BS, Prokop LJ, Jairath V, et al. Incremental Benefit of Achieving Endoscopic and Histologic Remission in Patients With Ulcerative Colitis: A Systematic Review and Meta-Analysis. GASTROENTEROLOGY. 2020;159(4):1262-75 e7.

"
  ["project_suppl_material"]=>
  bool(false)
  ["project_coi"]=>
  array(2) {
    [0]=>
    array(1) {
      ["file_coi"]=>
      array(21) {
        ["ID"]=>
        int(18953)
        ["id"]=>
        int(18953)
        ["title"]=>
        string(13) "COI_SunHo.pdf"
        ["filename"]=>
        string(13) "COI_SunHo.pdf"
        ["filesize"]=>
        int(19163)
        ["url"]=>
        string(62) "https://yoda.yale.edu/wp-content/uploads/2026/03/COI_SunHo.pdf"
        ["link"]=>
        string(59) "https://yoda.yale.edu/data-request/2026-0192/coi_sunho-pdf/"
        ["alt"]=>
        string(0) ""
        ["author"]=>
        string(4) "2201"
        ["description"]=>
        string(0) ""
        ["caption"]=>
        string(0) ""
        ["name"]=>
        string(13) "coi_sunho-pdf"
        ["status"]=>
        string(7) "inherit"
        ["uploaded_to"]=>
        int(18909)
        ["date"]=>
        string(19) "2026-03-17 19:19:22"
        ["modified"]=>
        string(19) "2026-03-17 19:19:26"
        ["menu_order"]=>
        int(0)
        ["mime_type"]=>
        string(15) "application/pdf"
        ["type"]=>
        string(11) "application"
        ["subtype"]=>
        string(3) "pdf"
        ["icon"]=>
        string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
      }
    }
    [1]=>
    array(1) {
      ["file_coi"]=>
      array(21) {
        ["ID"]=>
        int(18954)
        ["id"]=>
        int(18954)
        ["title"]=>
        string(14) "COI_Rirong.pdf"
        ["filename"]=>
        string(14) "COI_Rirong.pdf"
        ["filesize"]=>
        int(18136)
        ["url"]=>
        string(63) "https://yoda.yale.edu/wp-content/uploads/2026/03/COI_Rirong.pdf"
        ["link"]=>
        string(60) "https://yoda.yale.edu/data-request/2026-0192/coi_rirong-pdf/"
        ["alt"]=>
        string(0) ""
        ["author"]=>
        string(4) "2201"
        ["description"]=>
        string(0) ""
        ["caption"]=>
        string(0) ""
        ["name"]=>
        string(14) "coi_rirong-pdf"
        ["status"]=>
        string(7) "inherit"
        ["uploaded_to"]=>
        int(18909)
        ["date"]=>
        string(19) "2026-03-17 19:19:24"
        ["modified"]=>
        string(19) "2026-03-17 19:19:26"
        ["menu_order"]=>
        int(0)
        ["mime_type"]=>
        string(15) "application/pdf"
        ["type"]=>
        string(11) "application"
        ["subtype"]=>
        string(3) "pdf"
        ["icon"]=>
        string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
      }
    }
  }
  ["data_use_agreement_training"]=>
  bool(true)
  ["human_research_protection_training"]=>
  bool(true)
  ["certification"]=>
  bool(true)
  ["search_order"]=>
  string(1) "0"
  ["project_send_email_updates"]=>
  bool(false)
  ["project_publ_available"]=>
  bool(true)
  ["project_year_access"]=>
  string(0) ""
  ["project_rep_publ"]=>
  bool(false)
  ["project_assoc_data"]=>
  array(0) {
  }
  ["project_due_dil_assessment"]=>
  bool(false)
  ["project_title_link"]=>
  array(21) {
    ["ID"]=>
    int(18897)
    ["id"]=>
    int(18897)
    ["title"]=>
    string(28) "Data Request Approved Notice"
    ["filename"]=>
    string(32) "Data-Request-Approved-Notice.pdf"
    ["filesize"]=>
    int(195663)
    ["url"]=>
    string(81) "https://yoda.yale.edu/wp-content/uploads/2026/02/Data-Request-Approved-Notice.pdf"
    ["link"]=>
    string(77) "https://yoda.yale.edu/data-request/2026-0088/data-request-approved-notice-69/"
    ["alt"]=>
    string(0) ""
    ["author"]=>
    string(4) "1885"
    ["description"]=>
    string(0) ""
    ["caption"]=>
    string(0) ""
    ["name"]=>
    string(31) "data-request-approved-notice-69"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(18715)
    ["date"]=>
    string(19) "2026-03-10 19:58:49"
    ["modified"]=>
    string(19) "2026-03-10 19:58:49"
    ["menu_order"]=>
    int(0)
    ["mime_type"]=>
    string(15) "application/pdf"
    ["type"]=>
    string(11) "application"
    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_review_link"]=>
  bool(false)
  ["project_highlight_button"]=>
  string(0) ""
  ["request_data_partner"]=>
  string(0) ""
}
data partner
array(1) {
  [0]=>
  string(0) ""
}


pi country
array(0) {
}


pi affil
array(0) {
}


products
array(0) {
}


num of trials
array(1) {
  [0]=>
  string(1) "0"
}


res
array(1) {
  [0]=>
  string(1) "3"
}