Observational study on cancer cachexia subtypes
Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia
University of Rochester · NCT06073431
This study is trying to identify different types of weight and muscle loss in patients with advanced colorectal, lung, or pancreatic cancers to help improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 225 sites (Fort Smith, Arkansas and 224 other locations) |
| Trial ID | NCT06073431 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify distinct subtypes of cancer cachexia in patients with unresectable advanced colorectal, lung, or pancreatic cancers. It evaluates various factors such as symptoms, physical function, and blood biomarkers to understand the different causes of weight and muscle loss in these patients. Participants will complete surveys, undergo physical tests, and provide blood and tumor samples to build a comprehensive database that may inform future treatment strategies. The study also seeks to validate diagnostic phenotypes of cachexia and explore tumor-derived factors contributing to the condition.
Who should consider this trial
Good fit: Ideal candidates include patients with unresectable or stage IV non-small cell lung cancer, pancreatic adenocarcinoma, or colorectal cancer who are starting first-line systemic therapy.
Not a fit: Patients who have already received maintenance treatment after first-line therapy or those with earlier-stage cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for cancer cachexia, improving patient outcomes.
How similar studies have performed: While there have been studies on cancer cachexia, this approach of identifying distinct subtypes is relatively novel and may provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer * Note: Patients do not need to have cachexia to be eligible * Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks. * NOTE: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant treatment and have since recurred are still eligible if such treatment ended \> 6 months prior to enrollment. Patients receiving concurrent radiation with systemic therapy or received local therapy alone (surgery, radiation therapy \[RT\]) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Be able to understand, speak and read English * Be 18 years of age or older Exclusion Criteria: * Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee * Have any planned major surgeries within the next 3 months * Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer * Be pregnant
Where this trial is running
Fort Smith, Arkansas and 224 other locations
- Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States (RECRUITING)
- Rocky Mountain Cancer Centers-Aurora — Aurora, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Boulder Community Foothills Hospital — Boulder, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Rocky Mountain Cancer Centers - Centennial — Centennial, Colorado, United States (ACTIVE_NOT_RECRUITING)
- The Women's Imaging Center — Denver, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Colorado Blood Cancer Institute — Denver, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Rocky Mountain Cancer Centers-Midtown — Denver, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Rocky Mountain Cancer Centers-Rose — Denver, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Rocky Mountain Cancer Centers - Swedish — Englewood, Colorado, United States (ACTIVE_NOT_RECRUITING)
- The Melanoma and Skin Cancer Institute — Englewood, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Rocky Mountain Cancer Centers-Lakewood — Lakewood, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Rocky Mountain Cancer Centers-Littleton — Littleton, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Rocky Mountain Cancer Centers-Sky Ridge — Lone Tree, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Rocky Mountain Cancer Centers-Thornton — Thornton, Colorado, United States (ACTIVE_NOT_RECRUITING)
- Beebe South Coastal Health Campus — Millville, Delaware, United States (RECRUITING)
- Helen F Graham Cancer Center — Newark, Delaware, United States (RECRUITING)
- Medical Oncology Hematology Consultants PA — Newark, Delaware, United States (RECRUITING)
- Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States (RECRUITING)
- Beebe Health Campus — Rehoboth Beach, Delaware, United States (RECRUITING)
- Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States (RECRUITING)
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
- Northside Hospital — Atlanta, Georgia, United States (RECRUITING)
- Northeast Georgia Medical Center Braselton — Braselton, Georgia, United States (RECRUITING)
- John B Amos Cancer Center — Columbus, Georgia, United States (RECRUITING)
- Northside Hospital - Duluth — Duluth, Georgia, United States (RECRUITING)
- Northeast Georgia Medical Center-Gainesville — Gainesville, Georgia, United States (RECRUITING)
- The Longstreet Clinic - Gainesville — Gainesville, Georgia, United States (RECRUITING)
- Northside Hospital - Gwinnett — Lawrenceville, Georgia, United States (RECRUITING)
- Memorial Health University Medical Center — Savannah, Georgia, United States (RECRUITING)
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler — Savannah, Georgia, United States (RECRUITING)
- Tift Regional Medical Center — Tifton, Georgia, United States (RECRUITING)
- South Georgia Medical Center/Pearlman Cancer Center — Valdosta, Georgia, United States (RECRUITING)
- Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States (RECRUITING)
- Queen's Cancer Cenrer - POB I — Honolulu, Hawaii, United States (RECRUITING)
- Queen's Medical Center — Honolulu, Hawaii, United States (RECRUITING)
- Straub Clinic and Hospital — Honolulu, Hawaii, United States (RECRUITING)
- Queen's Cancer Center - Kuakini — Honolulu, Hawaii, United States (RECRUITING)
- Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States (RECRUITING)
- Hawaii Cancer Care - Westridge — ‘Aiea, Hawaii, United States (RECRUITING)
- Pali Momi Medical Center — ‘Aiea, Hawaii, United States (RECRUITING)
- Queen's Cancer Center - Pearlridge — ‘Aiea, Hawaii, United States (RECRUITING)
- The Queen's Medical Center - West Oahu — ‘Ewa Beach, Hawaii, United States (RECRUITING)
- OSF Saint Anthony's Health Center — Alton, Illinois, United States (RECRUITING)
- Advocate Good Shepherd Hospital — Barrington, Illinois, United States (RECRUITING)
- Illinois CancerCare-Bloomington — Bloomington, Illinois, United States (RECRUITING)
- Illinois CancerCare-Canton — Canton, Illinois, United States (RECRUITING)
- Memorial Hospital of Carbondale — Carbondale, Illinois, United States (RECRUITING)
- SIH Cancer Institute — Carterville, Illinois, United States (RECRUITING)
- Illinois CancerCare-Carthage — Carthage, Illinois, United States (RECRUITING)
+175 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Richard F Dunne — University of Rochester NCORP Research Base
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Pancreatic Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Colorectal Carcinoma, Unresectable Lung Non-Small Cell Carcinoma