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One drop, many cancers? a rapid test aims to spot cancer signals in blood, urine, or saliva
NCT ID NCT07741435
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This study evaluates a rapid test called Methylscape that measures DNA methylation patterns in body fluids like blood, urine, or saliva. The goal is to see if it can detect a cancer signal and even predict where the cancer started, using a single sample. Researchers will compare results from about 3,250 adults—some with biopsy-confirmed solid tumors and some cancer-free—to measure the test's accuracy. If it works, this could become a low-cost tool for catching multiple cancer types early and monitoring for relapse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Methylscape DNA methylation assay (a rapid diagnostic test measuring DNA methylation patterns in body fluids)
- What this could lead to
- If successful, this could lead to a simple, affordable blood, urine, or saliva test that detects multiple cancer types early and identifies where the cancer started, potentially improving survival odds.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't cure cancer directly. The test may not be accurate enough in real-world settings, and results from this Colombian population may not apply globally.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 3,250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Colombian adults (≥18 years) with biopsy-confirmed solid tumors selected by local incidence (emphasis on breast, lung, and gastric cancer) and age- and sex-matched cancer-free volunteers, recruited at a single cancer center (CTIC) in Bogotá, Colombia.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
RECRUITINGBogotá, Bogota D.C., 110131, Colombia
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