Clinical trial · Observational
Understanding New Cachexia Subtypes Through Observational Epidemiological Research
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Advanced Lung Non-Small Cell Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.80 |
| Advanced Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage IV Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IV Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Unresectable Colorectal Carcinoma | Colorectal Carcinoma |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Electronic health record review | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
| Physical functions assessments | Other | — | UNRESOLVED |
| Positron Emission Tomography (PET) | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (survey, function tests, biospecimen, actigraphy)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Other: Electronic health record review
- Other: Medical Device Usage and Evaluation
- Other: Physical functions assessments
- Procedure: Positron Emission Tomography (PET)
- Other: Survey Administration
Primary outcomes (2)
- measure
- Multiple distinct diagnostic cancer cachexia phenotypes
- timeFrame
- Baseline through study completion, assessed up to 1 year follow up
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available