Methylscape test in body fluids for multi-cancer detection in Colombia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study assesses how well the Methylscape methylation assay detects cancer signals across solid tumors and predicts the cancer signal origin. It uses body fluids to measure global DNA methylation patterns and detect cancer signals electrochemically on gold electrodes. The study includes three parts: an initial validation in 250 cancer patients, a large-scale comparison of 1,500 cancer patients to 1,500 cancer-free controls, and a relapse-following sub-study with serial samples from 300 early-stage patients. Processing occurs at CTIC in Bogotá with collaboration from Columbia University. The goal is to determine specificity and sensitivity for multi-cancer detection in a Colombian population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria (both cohorts):

* Failure to meet the general or cohort-specific inclusion criteria.
* Pregnancy.
* Organ transplant recipients.
* Use of demethylating agents (azacitidine, decitabine) or cytotoxic agents (including for autoimmune/inflammatory conditions).
* 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.

Where it's running

• Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
  Bogotá, Bogota D.C., Colombia Recruiting

Study contacts

• Study coordinator: Andrés Cardona, MD, MSc, PhD, MBA
• Email: acardona@fctic.org
• Phone: +573016348173

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.