Understanding New Cachexia Subtypes Through Observational Epidemiological Research

Part of paid clinical trials in Pleasanton, California.

Sponsor
Kaiser Permanente
Study ID
NCT07776353
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and archived tumor samples. A sub-sample undergo collection of stool samples.
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT scan
  • Electronic health record review — OTHER
    Electronic Health Record Review
  • Medical Device Usage and Evaluation — OTHER
    Wear actigraph
  • Physical functions assessments — OTHER
    Undergo physical function assessments including 30-second bicep curl, timed up and go (TUG), and 30-second sit to stand
  • Positron Emission Tomography (PET) — PROCEDURE
    Undergo PET/CT scan
  • Survey Administration — OTHER
    Complete surveys

Study Details

The UNCOVER study is a longitudinal observational cohort focused on patients at high risk for cancer cachexia. At Kaiser Permanente Northern California, up to 800 individuals with advanced or unresectable non-small cell lung cancer, pancreatic adenocarcinoma, or colorectal cancer will be enrolled, as these malignancies carry a substantial risk of cancer cachexia, which is characterized by progressive loss of weight, muscle, and adipose tissue, accompanied by functional decline and reduced quality of life. Data collected includes demographic, physiologic, and clinical data, including tumor characteristics and biomarkers of inflammation, hormonal and metabolic status, body composition, physical function, and patient reported outcomes. Investigators will identify patient phenotypes (i.e., subgroups) that may reflect distinct biological or clinical pathways underlying cancer cachexia. By characterizing heterogeneity in cancer cachexia, this study aims to inform the development of improved diagnostic criteria and more targeted therapeutic strategies, ultimately enhancing clinical trial design and supportive care for patients with advanced colorectal, lung, or pancreatic cancer.

Key Dates

First listed
Aug 20, 2026
Start date
Apr 5, 2023
Status verified
Jul 2026
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: Observational (survey, function tests, biospecimen, actigraphy)
    Patients complete surveys, undergo physical function tests, undergo collection of blood and archived tumor samples, and wear an actigraph over 24 hours for a week to record daily sleep and exercise activity at baseline and 3-month follow-up. A sub-sample of patients provide stool samples. Additionally, patients undergo standard of care CT or PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.

Primary Outcome Measure

Multiple distinct diagnostic cancer cachexia phenotypes [ Time Frame: Baseline through study completion, assessed up to 1 year follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Northern CaliforniaPleasantonCalifornia94588
Michelle C Ross, MPH
[email protected]
(925) 520-0650

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Kaiser Permanente Northern California· Pleasanton, CA

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