Overview
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.
Description
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.
Eligibility
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.
