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Understanding New Cachexia Subtypes Through Observational Epidemiological Research

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Kaiser Permanente Northern California
RECRUITING
Pleasanton
Contact Information
Primary
Elizabeth M Cespedes Feliciano, ScD, SM
Elizabeth.M.Cespedes@kp.org
(510) 414-4154
Backup
Michelle C Ross, MPH
michelle.c.ross@kp.org
(925) 520-0650
Time Frame
Start Date: 2023-04-05
Estimated Completion Date: 2028-05
Participants
Target number of participants: 800
Treatments
Observational (survey, function tests, biospecimen, actigraphy)
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.
Sponsors
Leads: Kaiser Permanente
Collaborators: Cancer Research UK, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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