NCT07741435Recruiting
Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia
Evaluation of a Rapid Test for the Detection of Methylation Profiles (Methylscape) in Various Body Fluids as a Universal Biomarker for Cancer Detection and Monitoring
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3250 (estimated)
- First submitted
- 23 Jun 2026
- Start date
- 5 Jun 2025
- Primary completion date
- 4 Jun 2027
- Lead sponsor
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
- NCT number
- NCT07741435
What you commit to
- Study type: Observational
- Planned participants: 3250
- From 5 Jun 2025 to the primary completion date, 4 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Organ transplant recipients.
- Prior or ongoing anticancer therapy: cancer surgery beyond that needed for diagnosis; local, regional, or systemic chemotherapy (including chemoembolization); targeted therapy; immunotherapy (including cancer vaccines); hormonal therapy; or radiotherapy.
Other illness
- Failure to meet the general or cohort-specific inclusion criteria.
- Use of demethylating agents (azacitidine, decitabine) or cytotoxic agents (including for autoimmune/inflammatory conditions).
Other
- Pregnancy.
Who the study is looking for
- Adults aged 18 years or older.
- Willing and able to participate and to provide the required samples (blood, urine, saliva) and demographic information (age, sex, race/ethnicity, BMI).
- Able to provide written informed consent for participation and for use of biological samples. For CTIC Biobank samples, prior research-use consent is verified.
- Demographic/anthropometric comparability (race, ethnicity, BMI) with other participants; race/ethnicity by self-identification (WHO and national census categories); BMI per WHO categories.
- Inclusion - Cancer cohort:
- Cancer diagnosis confirmed within 90 days prior to sample collection.
- Biopsy-proven malignancy with radiological staging.
- No anticancer treatment at the time of collection or within the previous 3 years.
- Inclusion - Cancer-free (healthy) cohort:
- No cancer diagnosis or treatment in the previous 3 years (ICD-O-3 behavior code 2 or 3).
- Not under evaluation for suspected cancer (verified by medical record review or additional medical evaluation).
- Subjects with benign tumors (code 0) or tumors of uncertain behavior (code 1) may be included if there is no clinical evidence of progression or malignancy.
- Additional criteria - tumor-burden monitoring (Sub-study 2b):
- Biopsy-confirmed cancer.
- ECOG performance status ≤ 2.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo Coordinator of this site? Confirm its status | Bogotá | Colombia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.