Evaluation of the Methylscape DNA Methylation Test in Body Fluids for Early Detection and Monitoring of Multiple Solid Cancers in Colombian Adults

What this Trial Is About

Researchers are evaluating the Methylscape test, a rapid assay that detects global DNA methylation patterns in body fluids to identify cancer signals and predict their origin. This prospective observational study focuses on Colombian adults with various biopsy-confirmed solid tumors and matched cancer-free volunteers. The goal is to assess the tests diagnostic performance, including sensitivity and specificity, as well as its potential as a multi-cancer early detection tool in an upper-middle-income Latin American setting. Participants include adults with recent cancer diagnoses and untreated status, as well as healthy volunteers without cancer diagnoses in the past three years. Blood, urine, saliva, and tumor tissue samples are collected for the Methylscape test, which measures differential DNA adsorption on gold electrodes. The study consists of three parts initial validation with 250 cancer patients, large-scale validation with 1,500 cancer patients and matched controls, and serial sampling in 300 early-stage patients to monitor disease relapse alongside standard imaging every six months. During the study, participants provide multiple biological samples and demographic information. Researchers collect blood, urine, saliva, and tumor tissue for analysis and follow early-stage patients with serial blood and urine tests to detect relapse. Measures include test sensitivity and specificity, cancer signal origin accuracy, and relapse detection compared with imaging or biopsy. The study also projects the budget impact and cost-effectiveness of implementing the test. Participation lasts through the study phases, with follow-up assessments for up to 24 months in some cases.

Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia