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NCT06073431 · ClinicalTrials.gov registry record
LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia
A clinical trial of Stage IV Lung Cancer AJCC v8 and Stage IV Pancreatic Cancer AJCC v8, sponsored by University of Rochester.
- Recruiting
- Registry status
- 800
- Enrollment target
- 20
- Study locations
NCT06073431: Recruiting study of Stage IV Lung Cancer AJCC v8 and Stage IV Pancreatic Cancer AJCC v8, sponsored by University of Rochester.
NCT06073431 is a study of Stage IV Lung Cancer AJCC v8 and Stage IV Pancreatic Cancer AJCC v8 that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 800 participants, above the 88-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (809% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06073431, a study of Stage IV Lung Cancer AJCC v8 and Stage IV Pancreatic Cancer AJCC v8, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- 800 participants
- Enrollment target
- 20
- Study locations
Study Summary
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) or is stage IV. 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 Outcome
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 va
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- OTHER Medical Device Usage and Evaluation
- OTHER Electronic Health Record Review
- OTHER Physical Performance Testing
Study Locations (20)
Colorado
- Rocky Mountain Cancer Centers-Aurora - Aurora
- Boulder Community Foothills Hospital - Boulder
- Rocky Mountain Cancer Centers-Boulder - Boulder
- Rocky Mountain Cancer Centers - Centennial - Centennial
- The Women's Imaging Center - Denver
- Colorado Blood Cancer Institute - Denver
- Rocky Mountain Cancer Centers-Midtown - Denver
- Rocky Mountain Cancer Centers-Rose - Denver
- Rocky Mountain Cancer Centers - Swedish - Englewood
- The Melanoma and Skin Cancer Institute - Englewood
- Rocky Mountain Cancer Centers-Lakewood - Lakewood
- Rocky Mountain Cancer Centers-Littleton - Littleton
- Rocky Mountain Cancer Centers-Sky Ridge - Lone Tree
- Rocky Mountain Cancer Centers-Thornton - Thornton
Delaware
- Beebe South Coastal Health Campus - Millville
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
- Christiana Care Health System-Christiana Hospital - Newark
- Beebe Health Campus - Rehoboth Beach
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2028-09-30 |
What NCT06073431 shows while recruiting
NCT06073431 is an observational study that tracks outcomes without assigning an intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 88-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (809% higher).
The record links to 9 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06073431 names 20 study sites across 3 states, led by Colorado, Delaware, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06073431 about?
NCT06073431 is a clinical study titled "LOTUS-CC: 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) or is stage IV. Patients with these cancer types are at risk for de...
What is the current status of trial NCT06073431?
This trial is currently recruiting. The enrollment target is 800 participants. The study started on 2023-12-04. Estimated completion is 2028-09-30.
What conditions does trial NCT06073431 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Advanced Lung Non-Small Cell Carcinoma, Advanced Colorectal Carcinoma.
What interventions are being tested in trial NCT06073431?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Medical Device Usage and Evaluation (OTHER), Electronic Health Record Review (OTHER), Physical Performance Testing (OTHER).
Who is sponsoring clinical trial NCT06073431?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06073431 being conducted?
This trial has 20 study locations across Arkansas, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06073431's enrollment target sits among peer trials
800 2nd of 81 the highest of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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