Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

800

participants targeted

Target at P75+ for all trials

Timeline

19mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.1 years study duration

Study Progress69%

Apr 2023May 2028

Study Start

First participant enrolled

April 5, 2023

Completed

3.4 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2026

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

August 20, 2026

Status Verified

July 1, 2026

Enrollment Period

4.1 years

First QC Date

August 17, 2026

Last Update Submit

August 17, 2026

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

Keywords

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesColorectal NeoplasmsLung NeoplasmsPancreatic NeoplasmsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemSpecimen HandlingExercise Test

Outcome Measures

Primary Outcomes (2)

Multiple distinct diagnostic cancer cachexia phenotypes
Phenotypes will be based on patient-reported symptoms, physical activity and function assessments, biomarkers, and body composition measured longitudinally using latent class analysis and other clustering methods.
Baseline through study completion, assessed up to 1 year follow up
Overall survival: time to death
Time to death will be assessed as the interval between phenotype ascertainment and death from any cause. Participants without a recorded death event will be censored at the end of available follow-up (e.g., end of health plan membership or the study observation period).
Baseline to death (the event) or the last contact (censored), assessed up to 1 year follow up

Secondary Outcomes (3)

Functional decline
Baseline through study completion, assessed up to 1 year follow up
Treatment intolerance
Baseline through study completion, assessed up to 1 year follow up
Early predictors of decline
Baseline through study completion, assessed up to 1 year follow up

Study Arms (1)

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.

Procedure: Biospecimen CollectionProcedure: Computed TomographyOther: Electronic health record reviewOther: Medical Device Usage and EvaluationOther: Physical functions assessmentsProcedure: Positron Emission Tomography (PET)Other: Survey Administration

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood and archived tumor samples. A sub-sample undergo collection of stool samples.

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection