Understanding New Cachexia Subtypes Through Observational Epidemiological Research

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKaiser Permanente

About this trial

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.

Eligibility criteria

Qualifiers

Have a primary diagnosis of unresectable or Stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer (CRC).

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.

Have an an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Be able to understand, speak and read English.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Electronic health record review
  • Medical Device Usage and Evaluation
  • Physical functions assessments
  • Positron Emission Tomography (PET)
  • Survey Administration

Treatment groups

800 Participants
are divided into 1 treatment group

Sponsors and collaborators

Kaiser Permanente

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Cancer Research UK

Collaborator