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Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia (METHYLSCAPE-CO)

tiistai 28. heinäkuuta 2026 päivittänyt: Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

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

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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

Background. Most cancers lack reliable screening methods, often leading to advanced-stage diagnosis. Multi-cancer early detection (MCED) tests based on body fluids can screen for several cancer types from a single sample. DNA methylation, which occurs early in carcinogenesis and is tissue-specific, is the most commonly used marker in MCED assays. Methylscape leverages global differences in the genomic distribution of methylation between cancerous and normal tissues, detected electrochemically through differential adsorption of DNA on gold electrodes.

Objective. To determine whether Methylscape can detect the methylation landscape across multiple cancer types with sufficiently high specificity to predict the cancer signal origin (CSO), and to assess its potential application as a population-scale MCED test among Colombians.

Design. Single-center prospective observational study conducted at CTIC (Bogotá, Colombia), with sample processing at CTIC and Columbia University. Phase 1 (N=250 patients with cancer) provides initial validation across solid tumor types selected by local incidence. Sub-study 2a (1,500 patients with cancer and 1,500 matched cancer-free volunteers) provides large-scale clinical validation. Sub-study 2b (N=300 early-stage patients) evaluates serial blood/urine Methylscape testing for relapse detection during follow-up every 6 months. Phase 1 participants may enter Sub-studies 2a/2b only if they meet the corresponding criteria and provide new informed consent; cross-phase participation is flagged in the database to adjust statistical estimates.

Biospecimens & reference standards. Blood/plasma (K2EDTA), urine, saliva, and FFPE tumor tissue are collected and stored at -80 °C in the CTIC biobank. Cancers are coded with WHO ICD-O-3; stage per AJCC 8th edition. Reference standards: histopathology (MCED), RECIST 1.1 or biopsy (relapse), and absence of cancer by record review plus 12-month follow-up (cancer-free).

Statistical analysis. Sensitivity and specificity are estimated overall and by stage/type (expected sensitivity 85-90%, specificity 98%; 95% confidence, 80% power). PPV/NPV are derived via Bayes' theorem with prevalence from GLOBOCAN 2022; 95% CIs by stratified bootstrap (1,000 resamples). Budget impact and cost-effectiveness (QALYs) are projected via microsimulation and Markov models.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Arvioitu)

3250

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

  • Nimi: Andrés Cardona, MD, MSc, PhD, MBA
  • Puhelinnumero: +573016348173
  • Sähköposti: acardona@fctic.org

Opiskelupaikat

  • Kolumbia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Kolumbia, 110131
        • Rekrytointi
        • Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
        • Ottaa yhteyttä:
          • Liliana Gutiérrez Babativa, RN, MSc
          • Puhelinnumero: +573003768158
          • Sähköposti: lgutierrez@fctic.org

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Joo

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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.

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Interventio / Hoito
Patients with cancer
Colombian adults (≥18 y) with biopsy-confirmed solid tumors (behavior code 3, ICD-O-3) diagnosed within 90 days and untreated. Provide blood, urine, saliva, and FFPE tumor tissue for Methylscape testing. An early-stage subset is followed with serial blood/urine sampling for relapse detection (Sub-study 2b).
Diagnostinen testi: Methylscape DNA methylation assay
Rapid assay measuring global DNA methylation patterns in body fluids (blood/plasma, urine, saliva) and FFPE tumor tissue via differential adsorption of methylated vs. unmethylated DNA on gold electrodes (differential pulse voltammetry), to detect a cancer signal and predict the cancer signal origin (CSO). Applied to both groups; no therapeutic intervention is administered.
Cancer-free (healthy) volunteers
Colombian adults (≥18 y) without cancer diagnosis or treatment in the prior 3 years, matched to cancer patients by sex, age, race/ethnicity, and BMI. Provide blood, urine, and saliva for Methylscape testing (Sub-study 2a).
Diagnostinen testi: Methylscape DNA methylation assay
Rapid assay measuring global DNA methylation patterns in body fluids (blood/plasma, urine, saliva) and FFPE tumor tissue via differential adsorption of methylated vs. unmethylated DNA on gold electrodes (differential pulse voltammetry), to detect a cancer signal and predict the cancer signal origin (CSO). Applied to both groups; no therapeutic intervention is administered.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Sensitivity of the Methylscape test for cancer-signal detection, as assessed against histopathological confirmation as the reference standard
Aikaikkuna: Baseline
Percentage of participants with biopsy-confirmed cancer who have a positive Methylscape result (cancer signal detected). Reported overall and by subgroup (cancer stage per AJCC 8th ed. and cancer type per ICD-O); all subgroups use the same unit. Adjusted by GLOBOCAN 2022 incidence.
Baseline
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
Aikaikkuna: 12 months
Percentage of confirmed cancer-free volunteers who have a negative Methylscape result (no cancer signal detected).
12 months

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Accuracy of Methylscape cancer-signal-origin (CSO) prediction, measured as the percentage of cases in which the predicted tissue of origin matches the histopathologically confirmed primary tumor site
Aikaikkuna: Baseline
Among participants with a positive Methylscape cancer signal, the percentage in which the Methylscape-predicted tissue of origin agrees with the confirmed primary site (ICD-O morphology code).
Baseline
Sensitivity and specificity of serial Methylscape testing for detection of disease relapse, as assessed against imaging response (RECIST 1.1) or biopsy of local recurrence
Aikaikkuna: At 6, 12, 18, and 24 months
In early-stage participants under follow-up (Sub-study 2b), sensitivity and specificity of serial blood/urine Methylscape testing for detecting disease relapse. Sensitivity and specificity are both reported as percentages (same unit of measure); the reference standard is radiological progression per RECIST 1.1 or biopsy-confirmed local recurrence.
At 6, 12, 18, and 24 months

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Positive and negative predictive value (PPV and NPV) of Methylscape for cancer-signal detection
Aikaikkuna: Up to 12 months
Positive predictive value (PPV) and negative predictive value (NPV) of the Methylscape cancer-signal result, both reported as percentages. Values are computed via Bayes' theorem using cancer prevalence estimated from GLOBOCAN 2022, with 95% confidence intervals obtained by stratified bootstrap (1,000 resamples). Reference standard: histopathological confirmation for cancer status and absence of cancer by medical-record review and 12-month follow-up for cancer-free status.
Up to 12 months
Diagnostic performance of Methylscape in cancers with versus without established screening programs
Aikaikkuna: Up to 12 months
Sensitivity and specificity of Methylscape, both reported as percentages, compared between cancers with established screening options (e.g., breast, cervical, lung) and cancers without standard screening. Reference standard: histopathological confirmation (sensitivity) and absence of cancer by medical-record review and 12-month follow-up (specificity).
Up to 12 months
Budget impact of implementing Methylscape as a multi-cancer early detection strategy
Aikaikkuna: Through study completion, an average of 24 months
Estimated incremental budget impact of introducing Methylscape as a multi-cancer early detection (MCED) and relapse-detection tool versus current screening and follow-up practice in the Colombian health system, reported in Colombian pesos (COP). Estimated using microsimulation and Markov models populated with study-derived diagnostic performance.
Through study completion, an average of 24 months
Cost-effectiveness of Methylscape (incremental cost-effectiveness ratio)
Aikaikkuna: Through study completion, an average of 24 months
Incremental cost-effectiveness ratio (ICER) of Methylscape versus current practice, reported as cost per quality-adjusted life-year (QALY) gained, in Colombian pesos per QALY (COP/QALY). Estimated using microsimulation and Markov models populated with study-derived diagnostic performance.
Through study completion, an average of 24 months

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

Julkaisuja ja hyödyllisiä linkkejä

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Yleiset julkaisut

Opintojen ennätyspäivät

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Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Torstai 5. kesäkuuta 2025

Ensisijainen valmistuminen (Arvioitu)

Perjantai 4. kesäkuuta 2027

Opintojen valmistuminen (Arvioitu)

Lauantai 15. tammikuuta 2028

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 23. kesäkuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 28. heinäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Maanantai 3. elokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 3. elokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 28. heinäkuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. heinäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • Methylscape
  • CEI-183 (Muu tunniste: Comité de Ética de la Investigación Riesgo de Fractura S.A)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

De-identified individual participant data (IPD) underlying the results reported in study publications will be made available, together with the corresponding data dictionary. Data will be shared in fully anonymized form, with direct and indirect identifiers removed in accordance with Colombian Law 1581 of 2012 on personal data protection. Sharing is subject to the approvals and conditions described under Access Criteria and to any constraints arising from the sponsor's intellectual-property rights in the Methylscape assay

IPD-jaon aikakehys

Data will become available beginning 6 months after publication of the primary results and will remain available until 5 years after the study completion date, consistent with the institutional data-retention period.

IPD-jaon käyttöoikeuskriteerit

Access will be granted to qualified researchers whose proposed use has been approved by the study sponsor and the Comité de Ética en Investigación. Requestors must submit a methodologically sound research proposal and execute a data access/use agreement. Requests should be directed to the principal investigator. Data will be shared through a secure, controlled-access mechanism, and no personally identifiable information will be released.

IPD-jakamista tukeva tietotyyppi

  • CSR

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