Recruiting

Cancer CachexiaUnderstanding New Cachexia Subtypes Through Observational Epidemiological Research

Sponsor:

Kaiser Permanente

Code:

NCT07776353

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography

Electronic health record review

Medical Device Usage and Evaluation

Physical functions assessments

Study Details

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.

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

Study ID

NCT07776353

Start date

Apr 5, 2023

Status verified date

Jul, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 (CRC).

Note: Patients do not need to have cachexia to be eligible

Plan to start first line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy) 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 therapy and have since recurred are still eligible if such treatment was longer than 6 months prior to enrollment.

Have an an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Be able to understand, speak and read English.
Be 18 years or older

Exclusion Criteria:

Have contraindications to physical function assessments (30-second bicep curl, Timed-Up-And-Go test, or 30-Second Sit to Stand test) per the treating provider or their designee.
Have any planned major surgeries within the next 3 months after enrollment to the best knowledge of the investigator/treating provider or their designee.
Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than non-melanoma skin cancer.
Be pregnant or within 6 months postpartum.

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

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

Computed Tomography

Undergo CT or PET/CT scan

Electronic health record review

Electronic Health Record Review

Medical Device Usage and Evaluation

Wear actigraph

Physical functions assessments

Undergo physical function assessments including 30-second bicep curl, timed up and go (TUG), and 30-second sit to stand

Positron Emission Tomography (PET)

Undergo PET/CT scan

Survey Administration

Complete surveys

Primary outcome measure

Multiple distinct diagnostic cancer cachexia phenotypes [ Time Frame: Baseline through study completion, assessed up to 1 year follow up ]
Overall survival: time to death [ Time Frame: Baseline to death (the event) or the last contact (censored), assessed up to 1 year follow up ]

Central Contacts and Locations

Central contacts

Elizabeth M Cespedes Feliciano, ScD, SM

(510) 414-4154 Elizabeth.M.Cespedes@kp.org

Michelle C Ross, MPH

(925) 520-0650 michelle.c.ross@kp.org

Locations

Kaiser Permanente Northern California

Recruiting

Pleasanton, California, United States, 94588

Contacts

Michelle C Ross, MPH

(925) 520-0650 michelle.c.ross@kp.org

More Information

Sponsor

Kaiser Permanente

Last update posted

Aug 20, 2026

Last verified

Jul, 2026

Keywords

Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Colorectal Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Clinical Laboratory Techniques
Diagnostic Techniques and Procedures
Diagnosis
Investigative Techniques
Heart Function Tests
Diagnostic Techniques, Cardiovascular
Respiratory Function Tests
Diagnostic Techniques, Respiratory System
Specimen Handling
Exercise Test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2026-08-20.