Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Potwierdzony nowotwór biopsją w ciągu 90 dni przed badaniem
- •Pacjenci bez leczenia przeciwnowotworowego w ostatnich 3 latach
- •Zdolność do wyrażenia pisemnej zgody na udział w badaniu
- •Dla grupy zdowych - brak raka w ostatnich 3 latach i niepodejrzewany nowotwór
- •Chęć pobrania próbek krwi, moczu i śliny
✗ Disqualifies
- •Ciąża
- •Przeszczep narządu
- •Przyjmowanie leków zmniejszających metylację DNA (azacytydyna, decytabyna)
- •Trwające lub przeszłe leczenie przeciwnowotworowe (chemioterapia, radioterapia, immunoterapia)
- •Pobieranie leków cytostatycznych (także na choroby autoimmunologiczne)
- •Niepełnienie kryteriów ogólnych lub grupowo-specyficznych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 3, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogotá, Colombia
Trial contact
Andrés Cardona, MD, MSc, PhD, MBA
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/4/2026.
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