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NCT Number: NCT07776353

Understanding New Cachexia Subtypes Through Observational Epidemiological Research

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.

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Key information

Conditions

Advanced Colorectal Carcinoma Advanced Lung Non-Small Cell Carcinoma Advanced Pancreatic Adenocarcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Stage IV Colorectal Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Thoracic Neoplasms Unresectable Colorectal Carcinoma Unresectable Lung Non-Small Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Northern California

Pleasanton, California, 94588, United States

Location status: Recruiting

Location contact

Michelle C Ross, MPH

CONTACT

[email protected]

(925) 520-0650

About this study

PRIMARY OBJECTIVES:

I. To identify multiple distinct diagnostic phenotypes within the syndrome of cancer cachexia as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for cancer cachexia.

II. To determine the association of each cancer cachexia phenotype with overall survival.

SECONDARY OBJECTIVES:

I. To determine the association of each cancer cachexia phenotype with functional decline and treatment intolerance.

II. To inform clinical practice guidelines for prompt recognition of patients likely to progress to refractory cachexia, identify early predictors apparent at clinical presentation of each cancer cachexia phenotype defined in the primary objective.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biospecimen Collection

Procedure

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

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Computed Tomography

Procedure

Undergo CT or PET/CT scan

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Electronic Health Record Review

Other

Electronic Health Record Review

Medical Device Usage and Evaluation

Other

Wear actigraph

Physical functions assessments

Other

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

Other names: Physical Fitness Testing, Physical Function Testing

Positron Emission Tomography (PET)

Procedure

Undergo PET/CT scan

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Survey Administration

Other

Complete surveys

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Functional decline

    Time frame: Baseline through study completion, assessed up to 1 year follow up

    Associations between each cancer cachexia phenotype and functional decline is a secondary outcome. Functional status will be measured at baseline and study completion by physical function assessments and patient-reported questionnaires.

  2. Treatment intolerance

    Time frame: Baseline through study completion, assessed up to 1 year follow up

    Treatment intolerance will be modeled as time to event outcomes. Treatment data including chemotherapy, targeted therapy, and immunotherapy will be obtained from the electronic medical record.

  3. Early predictors of decline

    Time frame: Baseline through study completion, assessed up to 1 year follow up

    Logistic regression will be used to identify patient characteristics apparent at clinical presentation that are early predictors of each cancer cachexia phenotype, focusing on the high-risk phenotypes that are associated with poor outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth M Cespedes Feliciano, ScD, SM

CONTACT

[email protected]

(510) 414-4154

Michelle C Ross, MPH

CONTACT

[email protected]

(925) 520-0650

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Cancer Research UK
  • National Cancer Institute (NCI)

Registry information

Acronym: UNCOVER

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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