NCT07776353 · Kaiser Permanente
Understanding New Cachexia Subtypes Through Observational Epidemiological Research
(UNCOVER)
What this study is about
The UNCOVER study is a longitudinal observational group of participants focused on patients at high risk for cancer cachexia.
View original scientific description
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.
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
Primary outcome measures
Multiple distinct diagnostic cancer cachexia phenotypes
Time frame: Baseline through study completion, assessed up to 1 year follow up
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.
Overall survival: time to death
Time frame: Baseline to death (the event) or the last contact (censored), assessed up to 1 year follow up
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Pleasanton, California
Collaborators
National Cancer Institute (NCI), Cancer Research UK
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations