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

NCT07741435 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3250

Last updated 2026-08-03

No results posted yet for this study

Summary

DNA methylation changes occur early and broadly during carcinogenesis. Methylscape is a rapid assay that detects global DNA methylation patterns in body fluids (blood, urine, and saliva) and may detect a cancer signal and predict the cancer signal origin (CSO) from a single fluid sample, using the differential interaction between methylated and unmethylated DNA and gold nanoparticles.

This prospective observational study evaluates the diagnostic performance (sensitivity and specificity) of the Methylscape test in Colombian patients with various biopsy-confirmed solid tumors compared with age- and sex-matched cancer-free (healthy) volunteers. The study is conducted in three parts: Phase 1 validates the assay in 250 patients with cancer; Sub-study 2a compares 1,500 patients with cancer against 1,500 matched cancer-free volunteers; and Sub-study 2b uses serial blood and urine sampling in 300 patients with early-stage disease to assess detection of disease relapse during follow-up, in parallel with standard imaging.

The study also estimates positive and negative predictive values (PPV/NPV) and projects the budget impact and cost-effectiveness of Methylscape as a multi-cancer early detection (MCED) tool in an upper-middle-income Latin American setting.

Conditions

  • Neoplasms
  • Solid Tumor
  • Breast Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Uterine Cervical Neoplasms
  • Colorectal Neoplasms
  • Urologic Neoplasms
  • Head and Neck Neoplasms
  • Early Detection of Cancer
  • Neoplasm Recurrence, Local

Interventions

DIAGNOSTIC_TEST

Methylscape DNA methylation assay

Rapid assay measuring global DNA methylation patterns in body fluids (blood/plasma, urine, saliva) and FFPE tumor tissue via differential adsorption of methylated vs. unmethylated DNA on gold electrodes (differential pulse voltammetry), to detect a cancer signal and predict the cancer signal origin (CSO). Applied to both groups; no therapeutic intervention is administered.

Sponsors & Collaborators

  • Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-05
Primary Completion
2027-06-04
Completion
2028-01-15

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07741435 on ClinicalTrials.gov