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      string(239) "NCT00060502 - A Phase II, Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Anti-TNF a Monoclonal Antibody (Infliximab) to Treat Cancer-Related Cachexia in Subjects With Pancreatic Cancer"
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      string(241) "https://dev-yoda.pantheonsite.io/clinical-trial/nct00060502-a-phase-ii-multicenter-randomized-double-blind-placebo-controlled-study-evaluating-the-efficacy-and-safety-of-anti-tnf-a-monoclonal-antibody-infliximab-to-treat-cancer-related-cach/"
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  ["project_title"]=>
  string(137) "Longitudinal Nutritional, Functional, and Inflammatory Changes and Overall Survival in Pancreatic Cancer Cachexia: Secondary RCT Analysis"
  ["project_narrative_summary"]=>
  string(842) "Cancer-related cachexia is common in advanced pancreatic cancer and is characterized by weight and muscle loss, declining physical function, and systemic metabolic abnormalities. Using de-identified participant-level data from trial NCT00060502, we will examine whether changes over time in nutritional/body-composition measures and physical function are associated with overall survival. Routinely available inflammatory laboratory measures will be explored when data completeness permits. Repeated measures of lean body mass, weight/BMI, Karnofsky Performance Status, 6-minute walk distance, fatigue and anorexia/cachexia-related quality of life will be evaluated. The goal is to identify clinically interpretable longitudinal markers that may improve prognostic assessment and inform supportive-care research in pancreatic cancer cachexia."
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  array(7) {
    ["first_name"]=>
    string(4) "Fuyu"
    ["last_name"]=>
    string(2) "Li"
    ["degree"]=>
    string(7) "MD, PhD"
    ["primary_affiliation"]=>
    string(18) "Sichuan University"
    ["email"]=>
    string(17) "lifuyu@scu.edu.cn"
    ["state_or_province"]=>
    string(7) "Chengdu"
    ["country"]=>
    string(5) "China"
  }
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    ["label"]=>
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  }
  ["project_funding_source"]=>
  string(135) "1.3.5 project for disciplines of excellence-Clinical Research Incubation Project, West China Hospital, Sichuan University (2021HXFH001)"
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1610) "Background: Cancer cachexia in pancreatic cancer is a multidimensional syndrome involving progressive tissue loss, functional decline, and systemic inflammation. The prognostic importance of longitudinal changes across these domains is incompletely characterized.



Objective: To determine whether longitudinal nutritional/body-composition and functional changes are associated with overall survival, and to explore inflammatory laboratory markers when sufficiently available.



Study Design: Secondary participant-level analysis of the randomized, double-blind, placebo-controlled phase II trial NCT00060502.



Participants: All randomized participants with survival data; individual analyses will include participants with the measurements required for the relevant longitudinal model.



Primary and Secondary Outcome Measure(s): The primary outcome is overall survival from randomization. Secondary outcomes are progression-free survival and longitudinal changes in lean body mass, body weight/BMI, Karnofsky Performance Status, 6-minute walk distance, FACIT-Fatigue, and FAACT/quality-of-life measures.



Statistical Analysis: Longitudinal trajectories will be described using mixed-effects models. Associations with survival will be evaluated using parsimonious Cox models and, where feasible, joint longitudinal-survival models adjusted a priori for age, sex, disease stage, treatment allocation, and baseline weight-loss category. Inflammatory-marker analyses will be exploratory and limited to markers with adequate participant coverage."
  ["project_brief_bg"]=>
  string(2510) "Cancer cachexia is a multifactorial syndrome characterized by involuntary weight loss, skeletal-muscle depletion, and progressive functional impairment driven by reduced nutritional intake and abnormal metabolism. It is especially prominent in pancreatic cancer and is associated with impaired quality of life, treatment tolerance, and survival. Contemporary cachexia frameworks emphasize that body weight alone does not fully represent the syndrome; body composition, physical function, and inflammatory or metabolic abnormalities provide complementary information.



NCT00060502 was a randomized, double-blind, placebo-controlled phase II study of infliximab plus gemcitabine versus placebo plus gemcitabine in patients with pancreatic cancer and cancer-related weight loss. The original trial primarily evaluated treatment effects, with change in lean body mass at 8 weeks as the primary endpoint. Major secondary assessments included overall survival, progression-free survival, Karnofsky Performance Status, and 6-minute walk distance, together with repeated quality-of-life and symptom assessments.



The proposed study addresses a different question from the original treatment comparison. Rather than re-estimating the efficacy of infliximab, we will use repeated participant-level measurements to characterize how nutritional/body-composition and functional status evolve over time and determine whether deterioration in these domains is associated with subsequent survival. This approach may identify clinically interpretable longitudinal features that better reflect progression of cancer cachexia than single baseline measurements.



The available YODA datasets include repeated assessments of KPS, laboratory parameters, vital signs, FAACT/FACIT measures, quality of life, walk-test performance, tumor response, and survival/follow-up. Because inflammatory cytokines in the original pharmacodynamic substudy were measured in only a small subset of participants, cytokine analyses will not constitute a confirmatory objective. Exploratory inflammatory analyses will instead be restricted to routine laboratory markers with sufficient participant coverage.



This study may improve understanding of the temporal relationship between cachexia-related deterioration and mortality and may inform prognostic assessment, endpoint selection, supportive-care strategies, and the design of future multimodal clinical trials for pancreatic cancer cachexia."
  ["project_specific_aims"]=>
  string(931) "Aim 1: Characterize longitudinal trajectories of nutritional/body-composition and functional measures during follow-up, including lean body mass, weight/BMI, Karnofsky Performance Status, 6-minute walk distance, fatigue, and anorexia/cachexia-related quality-of-life measures.



Aim 2: Evaluate whether baseline levels and longitudinal changes in these measures are associated with overall survival. We hypothesize that greater deterioration in body composition and physical function will be associated with higher subsequent mortality independent of key baseline clinical factors and randomized treatment allocation.



Aim 3: Exploratorily evaluate associations between routinely available inflammatory or hematologic laboratory measures and survival, limited to markers with adequate participant-level coverage. Sparsely measured pharmacodynamic cytokines will not be treated as confirmatory predictors."
  ["project_study_design"]=>
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    ["label"]=>
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  ["project_purposes"]=>
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      ["label"]=>
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    [1]=>
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      ["value"]=>
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      ["label"]=>
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  ["project_purposes_exp"]=>
  string(270) "Secondary prognostic and associational research evaluating longitudinal cachexia-related nutritional/body-composition, functional, and laboratory measures in relation to survival. The primary objective is not to re-estimate the randomized treatment effect of infliximab."
  ["project_research_methods"]=>
  string(1514) "Data will be obtained exclusively from NCT00060502 (Sponsor Protocol C0168T60), a Phase II randomized, double-blind, placebo-controlled trial in adults with newly diagnosed locally advanced or metastatic pancreatic adenocarcinoma (Stages II–IV), cancer-related unintended weight loss, and eligibility for gemcitabine therapy.



Inclusion criteria for the present analysis: All randomized participants will be considered eligible, irrespective of assigned treatment group. For the primary overall survival analysis, participants must have sufficient information to determine survival time and vital status or censoring status. For analyses of a specific longitudinal nutritional or functional measure, participants must have a baseline measurement and at least one post-baseline measurement of that measure. Participants with baseline data only may still contribute to analyses of baseline predictors.



Exclusion criteria: No additional demographic or clinical exclusion criteria will be imposed beyond the eligibility criteria of the parent trial. Participants without sufficient information to determine survival time or censoring status will be excluded from overall survival analyses. Participants without repeated measurements for a specific longitudinal variable will be excluded only from the analysis of that variable and will not be excluded from the overall study cohort.



No external participant-level datasets will be used or pooled with the YODA Project data."
  ["project_main_outcome_measure"]=>
  string(1200) "Primary outcome: Overall survival (OS), defined as time from randomization to death from any cause. Participants alive at the last documented follow-up will be censored at the date of last known survival status. OS will be analyzed as a time-to-event outcome.



Secondary outcome: Progression-free survival (PFS), defined according to the original trial protocol and Statistical Analysis Plan as time from randomization to documented disease progression or death, with censoring rules applied as specified in the original trial documentation. PFS will also be analyzed as a time-to-event outcome.



Longitudinal nutritional/body-composition and functional measures, including lean body mass, body weight/BMI where available, Karnofsky Performance Status, 6-minute walk distance, FACIT-Fatigue, and FAACT-related measures, are explanatory variables rather than study outcomes. Their baseline values and longitudinal changes will be evaluated as predictors of OS and, secondarily, PFS.



If an outcome cannot be reconstructed reliably from the shared data, any modification to its definition will be documented and justified in the final analysis and publication."
  ["project_main_predictor_indep"]=>
  string(2033) "The main independent variables are prespecified longitudinal measures of nutritional/body-composition and functional status.

Nutritional/body-composition predictors will include lean body mass (LBM), body weight, and body mass index (BMI), where available. LBM will be analyzed using the measurements collected in the parent trial. For each measure, the baseline value and repeated post-baseline measurements will be retained on their original continuous scale. Longitudinal change will be defined relative to the participant’s baseline value.

Functional predictors will include Karnofsky Performance Status (KPS), 6-minute walk distance, FACIT-Fatigue score, and FAACT-related measures reflecting anorexia/cachexia and functional well-being. These measures will likewise be analyzed using baseline and repeated post-baseline values on their original scales.

The principal exposure of interest is deterioration or improvement in these measures over time rather than a single arbitrarily selected follow-up value. In longitudinal-survival analyses, repeated measurements will be modeled as continuous time-varying trajectories. Where joint longitudinal-survival models are feasible, participant-specific estimated trajectories and/or rates of change will be related to the hazard of death. Complementary landmark analyses will evaluate prespecified change from baseline to approximately Week 8 and subsequent survival.

Continuous predictors will not be dichotomized using data-derived cut-points. Direction of change will be defined so that decreases in LBM, body weight, KPS, 6-minute walk distance, FACIT-Fatigue, and favorable FAACT scores represent clinical deterioration, according to the scoring conventions of the original instruments.

Randomized treatment assignment will not be considered a main predictor of interest; it will be retained as an adjustment variable. Inflammatory laboratory measures will be evaluated only as exploratory predictors if participant coverage and longitudina."
  ["project_other_variables_interest"]=>
  string(2017) "Variables used for sample characterization and multivariable adjustment will be prespecified and limited to clinically relevant factors available in the parent trial.

Demographic variables will include age at randomization (continuous, years) and sex (as recorded in the trial). Race/ethnicity will be summarized descriptively but not used for adjustment if categories are too sparse.

Disease-related variables will include tumor stage at randomization, categorized according to the parent trial strata (Stage II/III vs Stage IV), and baseline weight-loss category during the 30 days before randomization (≤5% vs >5%). Presence of liver metastasis and other tumor-history variables will be summarized descriptively and considered for exploratory adjustment only if data completeness and sample size permit.

Treatment-related variables will include randomized treatment assignment (placebo, infliximab 3 mg/kg, or infliximab 5 mg/kg), modeled categorically. Treatment assignment will be retained as an adjustment variable rather than a primary exposure.

For analyses in which a longitudinal measure is the predictor, its corresponding baseline value will be included when appropriate. Baseline BMI/lean body mass and baseline KPS will therefore be used selectively to control for initial nutritional/body-composition or functional status while avoiding over-adjustment for highly correlated variables.

Routine hematologic or biochemical laboratory variables may be summarized and explored as additional predictors only when participant coverage and longitudinal completeness are adequate. Sparsely measured pharmacodynamic cytokines will not be included in confirmatory multivariable models.

Because of the modest cohort size, models will be parsimonious. Covariates will be selected a priori on clinical grounds rather than by automated stepwise procedures, and variables with substantial missingness or sparse categories will not be included in primary adjusted models."
  ["project_stat_analysis_plan"]=>
  string(4744) "Analyses will be conducted in R using de-identified participant-level data from NCT00060502. The analysis is prognostic/associational and is not intended to re-estimate the causal treatment effect of infliximab.

Descriptive analyses: Baseline demographic, disease, treatment, nutritional/body-composition, functional, patient-reported, and laboratory characteristics will be summarized for the randomized cohort and by treatment group. Continuous variables will be reported as mean (SD) or median (IQR), as appropriate, and categorical variables as number (%). The timing and completeness of repeated measurements will be examined before modeling. Overall survival (OS) and progression-free survival (PFS) will be summarized using Kaplan-Meier methods.

Bivariate analyses: Unadjusted associations of each prespecified predictor with OS and PFS will be examined individually using Cox proportional-hazards models. Baseline continuous predictors will be modeled on their original scales. For repeated measures, change from baseline and observed trajectories will first be summarized graphically and with mixed-effects models. Data-driven cut-points will not be used.

Longitudinal analyses: Linear mixed-effects models will characterize within-participant trajectories in lean body mass (LBM), body weight/BMI, Karnofsky Performance Status (KPS), 6-minute walk distance, FACIT-Fatigue, and FAACT-related measures. Models will include time as a fixed effect and participant-specific random intercepts; random slopes and nonlinear time terms will be added only if supported by the observed data and model convergence. The prespecified core longitudinal predictors will be LBM, KPS, and 6-minute walk distance; other repeated measures will be considered secondary/exploratory predictors.

Multivariable survival analyses: Cox models will evaluate associations between baseline predictor values and OS (primary outcome), with PFS as a secondary outcome. Adjusted models will be parsimonious and include clinically prespecified covariates: age, sex, tumor stage (Stage II/III vs Stage IV), baseline weight-loss category (≤5% vs >5% during the 30 days before randomization), and randomized treatment assignment, subject to data completeness and model stability. The corresponding baseline value of a longitudinal predictor will be included when change from baseline is modeled. Highly correlated variables will not be entered simultaneously.

An approximately 8-week landmark analysis will assess change from baseline to the assessment closest to Week 8 and subsequent OS among participants alive and under follow-up at the landmark. This analysis will be interpreted conditionally on survival to the landmark and not as a causal treatment analysis.

Advanced longitudinal-survival analysis: For core measures with adequate repeated observations, joint longitudinal-survival models will be used to relate participant-specific longitudinal trajectories to the hazard of death while accounting for measurement error and dropout related to death. Separate joint models will be fitted for individual core predictors rather than a high-dimensional multivariate joint model because of the modest sample size. If joint models are unstable or not estimable, the mixed-effects and landmark Cox analyses will remain the primary longitudinal approaches.

Missing data: The amount and pattern of missingness will be reported by variable and time point. Mixed-effects and joint models will use all available repeated observations under their assumptions. For baseline covariates, multiple imputation by chained equations may be used if missingness is nontrivial and a missing-at-random assumption is plausible; complete-case analyses will be used as sensitivity analyses. Death and progression events will not be imputed.

Model checking and sensitivity analyses: Proportional-hazards assumptions will be assessed using Schoenfeld residuals. Nonlinearity of continuous predictors will be evaluated, with restricted cubic splines considered only when supported by sample size. Influential observations and model convergence will be examined. Treatment-by-predictor interactions will be exploratory only.

Effect estimates will be reported with 95% confidence intervals. Given the modest sample size, emphasis will be placed on effect magnitude, precision, consistency, and clinical interpretation rather than isolated statistical significance. Secondary and inflammatory laboratory analyses will be considered exploratory; inflammatory markers will be analyzed only when participant coverage is adequate. Any deviation from this prespecified plan will be documented and justified in the final publication."
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      ["label"]=>
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  ["project_timeline"]=>
  string(1428) "Anticipated project start: October 2026. Following data access, the first 1–2 months will be used to review the trial documentation, map variables across datasets, assess data completeness and missingness, reconstruct prespecified outcomes, and finalize the analysis-ready longitudinal dataset.



Data cleaning and descriptive analyses: October–December 2026. Baseline characteristics, longitudinal measurement patterns, and Kaplan–Meier analyses will be completed during this period.



Primary statistical analyses: January–March 2027. Mixed-effects models, Cox regression, 8-week landmark analyses, and, where feasible, joint longitudinal-survival models will be performed. Prespecified sensitivity analyses and model diagnostics will also be completed.



Analysis completion: March 2027.



Manuscript drafting: April–May 2027. Tables, figures, interpretation of findings, and internal scientific review will be completed.



First manuscript submission: June 2027.



Results reported back to the YODA Project: August 2027, including manuscript/publication information and any other required study-result reporting.



If access is granted later than anticipated, milestone dates will shift accordingly while maintaining the same sequence of activities and aiming to complete the project within the 12-month data-access period."
  ["project_dissemination_plan"]=>
  string(1254) "The primary anticipated product is one peer-reviewed original research manuscript reporting the associations between longitudinal nutritional/body-composition and functional changes and survival in patients with pancreatic cancer-related cachexia. The target audience includes clinicians and researchers in pancreatic cancer, medical oncology, cancer cachexia, supportive oncology, clinical nutrition, and outcomes research.



Depending on the strength and clinical relevance of the findings, potentially suitable journals include Journal of Cachexia, Sarcopenia and Muscle, Clinical Nutrition, Supportive Care in Cancer, Pancreatology, or another peer-reviewed journal appropriate to the final scope of the study.



Findings may also be submitted as an abstract for presentation at relevant oncology, pancreatic disease, nutrition, or cachexia scientific meetings. Results will be reported transparently regardless of statistical significance, with appropriate acknowledgment of the YODA Project and the original data provider in accordance with the Data Use Agreement.



Study completion, resulting manuscripts, publications, and other dissemination products will be reported back to the YODA Project as required."
  ["project_bibliography"]=>
  string(1158) "

Fearon K, Strasser F, Anker SD, et al. Definition and classification of cancer cachexia: an international consensus. Lancet Oncology. 2011;12(5):489–495. doi:10.1016/S1470-2045(10)70218-7.
Martin L, Senesse P, Gioulbasanis I, et al. Diagnostic criteria for the classification of cancer-associated weight loss. Journal of Clinical Oncology. 2015;33(1):90–99. doi:10.1200/JCO.2014.56.1894.
Baracos VE, Martin L, Korc M, Guttridge DC, Fearon KCH. Cancer-associated cachexia. Nature Reviews Disease Primers. 2018;4:17105. doi:10.1038/nrdp.2017.105.
Wiedenmann B, Malfertheiner P, Friess H, et al. A multicenter, phase II study of infliximab plus gemcitabine in pancreatic cancer cachexia. Journal of Supportive Oncology. 2008;6(1):18–25. PMID: 18257397.
Martin L, Muscaritoli M, Bourdel-Marchasson I, et al. Diagnostic criteria for cancer cachexia: reduced food intake and inflammation predict weight loss and survival in an international, multi-cohort analysis. Journal of Cachexia, Sarcopenia and Muscle. 2021;12(5):1189–1202. doi:10.1002/jcsm.12756.

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