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      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"
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      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"
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      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/"
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  ["project_title"]=>
  string(134) "Fecal Lactoferrin as a Biomarker of Disease Activity, Mucosal Healing, and Treatment Response in Moderate-to-Severe Ulcerative Colitis"
  ["project_narrative_summary"]=>
  string(838) "UC is a chronic IBD that requires repeated assessment of disease activity to guide treatment decisions. Endoscopy remains the standard method for evaluating disease severity but is invasive, expensive, and burdensome for patients. Fecal biomarkers provide a non-invasive alternative for monitoring intestinal inflammation.  Although lactoferrin is used clinically, its ability to accurately reflect disease severity and predict treatment outcomes remains incompletely characterized. This study will use participant-level data to investigate relationships between fecal LTF concentrations, disease activity, endoscopic healing, histologic remission. The results will improve understanding of lactoferrin as a clinically useful biomarker and may help support less invasive disease monitoring strategies for patients with ulcerative colitis."
  ["project_learn_source"]=>
  string(12) "scien_public"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(7) "Shaohua"
    ["last_name"]=>
    string(2) "Ma"
    ["degree"]=>
    string(3) "PhD"
    ["primary_affiliation"]=>
    string(19) "Tsinghua University"
    ["email"]=>
    string(29) "ma.shaohua@sz.tsinghua.edu.cn"
    ["state_or_province"]=>
    string(9) "Guangdong"
    ["country"]=>
    string(5) "China"
  }
  ["project_key_personnel"]=>
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      ["p_pers_f_name"]=>
      string(8) "Canyucel"
      ["p_pers_l_name"]=>
      string(6) "Gungor"
      ["p_pers_degree"]=>
      string(7) "Masters"
      ["p_pers_pr_affil"]=>
      string(19) "Tsinghua University"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
    }
    [1]=>
    array(6) {
      ["p_pers_f_name"]=>
      string(6) "George"
      ["p_pers_l_name"]=>
      string(7) "Nicolas"
      ["p_pers_degree"]=>
      string(9) "Bachelors"
      ["p_pers_pr_affil"]=>
      string(19) "Tsinghua University"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(2) "no"
    }
  }
  ["project_ext_grants"]=>
  array(2) {
    ["value"]=>
    string(3) "yes"
    ["label"]=>
    string(65) "External grants or funds are being used to support this research."
  }
  ["project_funding_source"]=>
  string(71) "National Key Research and Development Program of China (2024YFA0919800)"
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1653) "Background



UC is a chronic inflammatory bowel disease characterized by relapsing intestinal inflammation and progressive tissue damage. Accurate assessment is essential for treatment; however, endoscopic evaluation is invasive, costly, and burdensome for patients. Fecal lactoferin has been associated with inflammatory bowel disease activity, but its relationship with outcomes in large randomized clinical trial populations remains incompletely characterized.



Objective



To evaluate the association between fecal lactoferrin concentrations and disease activity, inflammatory burden, mucosal healing, and treatment response in patients.



Study Design



Retrospective secondary analysis of participant-level data from the Phase III UNIFI randomized controlled trial (NCT02407236).



Participants



Adult patients with moderate-to-severe ulcerative colitis enrolled who have fecal lactoferrin measurements and clinical outcome data.



Primary and Secondary Outcome Measures



The primary outcome will be disease activity measured by Mayo score. Secondary outcomes include clinical remission, clinical response, endoscopic improvement, histologic remission, fecal calprotectin concentrations, C-reactive protein (CRP) concentrations, Inflammatory Bowel Disease Questionnaire (IBDQ) scores, and longitudinal treatment response.



Statistical Analysis



Associations between lactoferrin and continuous outcomes will be evaluated using Spearman correlation and multivariable linear regression.



"
  ["project_brief_bg"]=>
  string(2370) "Ulcerative colitis (UC) is a chronic inflammatory bowel disease that affects millions of individuals worldwide and requires continuous monitoring of disease activity to guide treatment decisions. Current treatment strategies increasingly emphasize objective assessment of inflammation and achievement of mucosal healing. Although endoscopy remains the gold standard for evaluating disease activity, it is invasive, expensive, and unsuitable for frequent monitoring. Consequently, there is significant interest in reliable non-invasive biomarkers that accurately reflect intestinal inflammation and predict treatment outcomes.



Fecal lactoferrin is an iron-binding glycoprotein released by activated neutrophils during intestinal inflammation. Elevated lactoferrin concentrations have been observed in patients with active inflammatory bowel disease and have been proposed as a surrogate marker of disease activity. Despite increasing clinical use, important questions remain regarding the quantitative relationship between lactoferrin and established clinical, endoscopic, and histologic outcome measures, particularly within large longitudinal clinical trial populations.



The Phase III UNIFI trial represents a unique opportunity to investigate these relationships because it includes standardized assessments of fecal lactoferrin, clinical disease activity, endoscopic outcomes, histologic outcomes, inflammatory biomarkers, and quality-of-life measures collected prospectively over time. By leveraging participant-level data from a large, well-characterized cohort of patients with moderate-to-severe UC, this study will provide a comprehensive evaluation of lactoferrin as a biomarker of disease severity and treatment response.



The proposed research will generate clinically relevant evidence regarding the utility of fecal lactoferrin for monitoring disease activity, predicting treatment outcomes, and assessing mucosal healing. Improved understanding of lactoferrin may facilitate broader adoption of non-invasive disease monitoring strategies, reduce dependence on repeated endoscopic procedures, and improve patient management. The findings will contribute generalizable knowledge regarding biomarker-guided monitoring approaches in ulcerative colitis and may inform future clinical studies and treatment algorithms."
  ["project_specific_aims"]=>
  string(1459) "Aim 1: Determine the relationship between fecal lactoferrin concentrations and ulcerative colitis disease activity.



Hypothesis 1: Higher fecal lactoferrin concentrations are associated with greater disease activity as measured by Mayo score.



Aim 2: Evaluate the association between fecal lactoferrin and objective markers of intestinal inflammation.



Hypothesis 2: Fecal lactoferrin concentrations positively correlate with fecal calprotectin concentrations, CRP levels, endoscopic disease activity, and histologic inflammation.



Aim 3: Assess whether baseline lactoferrin concentrations and longitudinal changes in lactoferrin predict treatment response.



Hypothesis 3: Lower baseline lactoferrin concentrations and larger reductions during treatment are associated with increased likelihood of clinical remission, endoscopic improvement, and histologic remission.



Aim 4: Compare the performance of lactoferrin with established inflammatory biomarkers.



Hypothesis 4: Lactoferrin provides comparable or complementary predictive information relative to fecal calprotectin and CRP for assessing disease activity and treatment response.



Collectively, these aims will provide a comprehensive assessment of fecal lactoferrin as a clinically useful biomarker for disease monitoring and therapeutic response in moderate-to-severe ulcerative colitis."
  ["project_study_design"]=>
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    ["value"]=>
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    ["label"]=>
    string(25) "Individual trial analysis"
  }
  ["project_purposes"]=>
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    [0]=>
    array(2) {
      ["value"]=>
      string(50) "research_on_clinical_prediction_or_risk_prediction"
      ["label"]=>
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  ["project_research_methods"]=>
  string(986) "The study will utilize participant-level data from the Phase III UNIFI trial (NCT02407236), a randomized, placebo-controlled clinical trial evaluating ustekinumab induction and maintenance therapy in adults with moderate-to-severe ulcerative colitis.



Study Population



The primary study population will consist of all trial participants with available fecal lactoferrin measurements and corresponding clinical outcome data.



Inclusion Criteria



Availability of baseline fecal lactoferrin measurements.

Availability of Mayo score data at baseline.

Availability of at least one relevant clinical, endoscopic, histologic, or biomarker outcome measure included in the analysis.



Exclusion Criteria



Missing baseline fecal lactoferrin measurements.

Missing primary outcome data required for the specific analysis.

Withdrawal prior to collection of baseline efficacy assessments."
  ["project_main_outcome_measure"]=>
  string(1019) "Primary Outcome Measure



The primary outcome will be disease activity measured using the Mayo score. Mayo score will be analyzed as a continuous variable to assess the relationship between fecal lactoferrin concentration and overall disease severity.



Secondary Outcome Measures



Clinical Remission: Defined according to the protocol-defined UNIFI endpoint and analyzed as a binary outcome (yes/no).

Clinical Response: Defined according to protocol criteria and analyzed as a binary outcome.

Endoscopic Improvement: Defined using protocol-specified endoscopic scoring criteria and analyzed as a binary outcome.

Histologic Remission: Defined using protocol-specified histologic assessment criteria and analyzed as a binary outcome.

Histologic Improvement: Defined according to trial-specific histologic endpoints and analyzed as a binary outcome.

Fecal Calprotectin Concentration: Analyzed as a continuous biomarker of intestinal inflammation."
  ["project_main_predictor_indep"]=>
  string(1108) "The primary independent variable is fecal lactoferrin concentration measured from stool samples collected at baseline and during follow-up assessments.



For the primary analysis, fecal lactoferrin concentration will be analyzed as a continuous variable. Because biomarker concentrations are expected to demonstrate a right-skewed distribution, logarithmic transformation will be performed when appropriate to satisfy model assumptions and improve model fit.



For secondary analyses, fecal lactoferrin concentrations will be categorized into quartiles based on the observed distribution within the study population to facilitate clinical interpretation and assess potential dose-response relationships. Additional clinically relevant threshold-based categories may be explored, where supported by existing literature, to evaluate the predictive performance of elevated versus lower fecal lactoferrin concentrations.



Associations between fecal lactoferrin levels and study outcomes will be assessed using both unadjusted and multivariable-adjusted statistical models."
  ["project_other_variables_interest"]=>
  string(1197) "Demographic variables will include age (continuous, years), sex (male/female), race/ethnicity (categorized according to available study data), and body mass index (continuous, kg/m²).



Disease-related variables will include disease duration (continuous, years since diagnosis), extent of ulcerative colitis involvement. Clinical disease activity scores will be analyzed as continuous variables and may additionally be categorized as remission, mild, moderate, or severe disease according to established criteria. Endoscopic activity will be assessed using the Mayo Endoscopic Subscore and categorized as remission (score 0–1) versus active disease (score 2–3), with additional analyses using individual score categories when appropriate.



Laboratory variables will include C-reactive protein (CRP), and fecal calprotectin concentrations. Continuous laboratory measurements may be log-transformed if substantially skewed.



Treatment-related variables will include baseline and follow-up use of aminosalicylates, corticosteroids, immunomodulators, biologic therapies, and small-molecule therapies. Prior biologic exposure will be categorized as yes/no."
  ["project_stat_analysis_plan"]=>
  string(2466) "All analyses will be conducted using R, RStudio, and Python within the YODA secure analysis environment.



Descriptive Analysis



Baseline demographic, clinical, endoscopic, histologic, and biomarker characteristics will be summarized using means and standard deviations or medians and interquartile ranges for continuous variables and frequencies and percentages for categorical variables. Distributional properties of fecal lactoferrin will be assessed and transformed where necessary.



Bivariate Analysis



Associations between fecal lactoferrin and continuous outcomes including Mayo score, fecal calprotectin, CRP, and IBDQ score will be evaluated using Spearman correlation coefficients.



Differences in lactoferrin concentrations across categorical outcome groups (clinical remission, endoscopic improvement, histologic remission) will be assessed using Mann-Whitney U tests or Kruskal-Wallis tests as appropriate.



Multivariable Analysis



Aim 1: Multivariable linear regression models will assess the relationship between lactoferrin concentration and Mayo score while adjusting for age, sex, disease duration, prior biologic exposure, treatment assignment, and baseline disease characteristics.



Aim 2: Associations between lactoferrin and objective inflammatory markers will be evaluated using multivariable linear regression models with CRP, fecal calprotectin, and other available inflammatory measures as dependent variables.



Aim 3: Multivariable logistic regression models will evaluate whether baseline lactoferrin concentrations independently predict:



• Clinical remission

• Clinical response

• Endoscopic improvement

• Histologic remission



Odds ratios and 95% confidence intervals will be reported.



Longitudinal Analysis: Repeated-measures mixed-effects models will evaluate relationships between lactoferrin trajectories and changes in disease activity over time.



Models will include fixed effects for time, treatment assignment, baseline disease severity, and lactoferrin concentration.



Comparative Biomarker Analysis: predictive performance of lactoferrin will be compared with CRP and fecal calprotectin individually and in combined models to determine whether lactoferrin provides complementary clinical information."
  ["project_software_used"]=>
  array(3) {
    [0]=>
    array(2) {
      ["value"]=>
      string(6) "python"
      ["label"]=>
      string(6) "Python"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(1) "r"
      ["label"]=>
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    [2]=>
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      ["value"]=>
      string(7) "rstudio"
      ["label"]=>
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  ["project_timeline"]=>
  string(840) "PROJECT TIMELINE



August 2026

Data access approval, dataset review, protocol review, and variable identification.

Data cleaning, quality assessment, harmonization of variables, and development of analysis scripts.



September 2026

Completion of primary analyses examining associations between lactoferrin and disease activity.

Completion of secondary analyses including remission, endoscopic improvement, histologic outcomes, and biomarker comparisons.

Longitudinal modeling, predictive analyses, sensitivity analyses, and preparation of figures and tables.



October 2026

Manuscript drafting, internal review, and revision.



December 2026

Submission of manuscript to a peer-reviewed journal and reporting of results to the YODA Project."
  ["project_dissemination_plan"]=>
  string(643) "The primary product is a peer-reviewed scientific manuscript describing the relationship between fecal lactoferrin, disease activity, and treatment outcomes in moderate-to-severe ulcerative colitis.



The target audience includes gastroenterologists, inflammatory bowel disease specialists, clinical researchers, translational scientists, and healthcare professionals involved in biomarker-guided disease monitoring.



Potential journals for submission include Inflammatory Bowel Diseases, Clinical Gastroenterology and Hepatology, Digestive Diseases and Sciences, Alimentary Pharmacology & Therapeutics, and Gut."
  ["project_bibliography"]=>
  string(614) "
Langhorst J, et al. Elevated human beta-defensin-2 levels indicate an activation of the innate immune system in patients with irritable bowel syndrome. Am J Gastroenterol. 2009.
Sipponen T, Kolho KL. Fecal calprotectin and lactoferrin are reliable surrogate markers of endoscopic response during Crohn’s disease treatment. Inflamm Bowel Dis. 2010.
Sands BE, et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2019.
Pai RK, et al. Fecal lactoferrin trajectories and remission outcomes in ulcerative colitis. Pathogens and Immunity. 2023.
"
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    string(0) ""
    ["caption"]=>
    string(0) ""
    ["name"]=>
    string(34) "yoda-project-review-2026-0528_site"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(19497)
    ["date"]=>
    string(19) "2026-08-19 16:56:12"
    ["modified"]=>
    string(19) "2026-08-19 16:56:12"
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    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_highlight_button"]=>
  string(0) ""
  ["request_data_partner"]=>
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}
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]=>
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}