Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring i… (NCT07741435) | Clinical Trial Compass
RecruitingNot Applicable
Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia
Colombia3,250 participantsStarted 2025-06-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 demethylati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of the Methylscape test for cancer-signal detection, as assessed against histopathological confirmation as the reference standard
Timeframe: Baseline
2
Specificity of the Methylscape test for cancer-signal detection, as assessed against absence of cancer confirmed by medical-record review and 12-month follow-up
Timeframe: 12 months
Trial details
NCT IDNCT07741435
SponsorCentro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo