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2023-12-04
2030-10-03
2031-08-21
800
NCT06073431
University of Rochester
University of Rochester
OBSERVATIONAL
An Observational Research Study to Uncover Subtypes of Cancer Cachexia
This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable). Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.
PRIMARY OBJECTIVE: I. To identify multiple distinct diagnostic subtypes within the syndrome of CC as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC. SECONDARY OBJECTIVES: I. To determine the association of each CC phenotype with overall survival. II. To validate CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by our collaborators at Kaiser Permanente. III. To collect human samples of blood, tumor tissue, and medical images and build a large, comprehensive CC database clinically annotated with cancer-related outcomes, cachexia symptoms, and physical function data. EXPLORATORY OBJECTIVE: I. To evaluate for tumor-derived factors contributing to CC by determining the association between interleukin-6 (IL-6) expression in tumor and IL-6 and CC chemokine ligand 2 (CCL2) levels in the blood in patients with CC. OUTLINE: This is an observational study. Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Additionally, patients undergo standard of care positron emission tomography (PET)/computed tomography (CT) scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-10-03 | N/A | 2025-05-06 |
2023-10-03 | N/A | 2025-05-11 |
2023-10-10 | N/A | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Observational (survey, function tests, biospecimen, actigraph) Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-m | PROCEDURE: Biospecimen Collection
PROCEDURE: Computed Tomography
OTHER: Electronic Medical Record
OTHER: Medical Device Usage and Evaluation
OTHER: Physical Performance Testing
PROCEDURE: Positron Emission Tomography
OTHER: Survey Administration
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC) | Defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC. First, will examine the distributions of each variable and assess the need for using transformations to achieve normality for continuous variables (log transformation, quartiles, or clinically important thresholds), collapsing similar variables into single categories, and excluding g conditions that are too rare (< 1% of the cohort). Next, will assess statistical correlations using the Jaccard similarity metric for binary variables and the Pearson correlation for continuous variables to determine highly correlated variables that may provide redundant information. | Baseline through study completion, assessed up to 1 year follow up |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Association of each CC phenotype (clusters) with overall survival | Will be assessed in the Cox regression model. Will estimate the bivariate association where the only independent variables will be the indicators for the cluster membership. Will report the hazard ratio for the association of each CC phenotype, specifying the lowest-risk cluster as the reference. Will assess the influence of selected factors (e.g., age, performance status, and other known prognostic factors) on the association of the cluster with survival by adding the factor to the model as a covariate and keeping those that resulted in 10% or more change in any regression coefficients for cluster membership. Will assess if the association of clusters with survival varies by specific subgroups (e.g., older versus younger age, gender, and cancer type). Will assess the statistical significance interaction of the subgroup with the cluster membership by maximum likelihood test and evaluate the regression coefficients for clusters in each subgroup comparing the direction and magnitude. | Days from registration (day 0) to death (the event) or the last contact (censored), assessed up to 1 year follow up |
| Validation of CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by collaborators at Kaiser Permanente | Study participants will be categorized into the Kaiser Permanente Medical Care (KPMC)-derived CC phenotype groups. Will use the final latent class analysis model fit in the KPMC data to compute the posterior probabilities of membership in each latent class for each individual National Cancer Institute Community Oncology Research Program (NCORP) participant based on his/her individual data. Will compare cluster prevalence in each cohort as well as the distributions of the variables used to determine each cluster to investigate patterns of commonality and dissimilarity across the contributing variables. Validation will be determined by fitting University of Rochester Cancer Center (URCC) NCORP participants in KPMC-derived clusters and evaluating each cluster's association with survival. If the ranking of survival (best to worst) among each cluster in the URCC NCORP dataset mirrors the prognostic ranking of clusters in the KPMC dataset, the clusters will be deemed validated. | Up to study completion, assessed up to 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Ashley Mack, MS Phone Number: 585-275-1090 Email: URCC_22063@urmc.rochester.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
