Understanding New Cachexia Subtypes Through Observational Epidemiological Research

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
• Stage IV Pancreatic Cancer AJCC v8
• Unresectable Colorectal Carcinoma
• Unresectable Lung Non-Small Cell Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

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

PROCEDURE

Computed Tomography

Undergo CT or PET/CT scan

OTHER

Electronic health record review

Electronic Health Record Review

OTHER

Medical Device Usage and Evaluation

Wear actigraph

OTHER

Physical functions assessments

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

PROCEDURE

Positron Emission Tomography (PET)

Undergo PET/CT scan

OTHER

Survey Administration

Complete surveys

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Cancer Research UK

  collaborator OTHER

• Kaiser Permanente

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-05

Primary Completion

2027-05-31

Completion

2028-05-31

Countries

• United States

Study Locations