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

28. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

3250

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Andrés Cardona, MD, MSc, PhD, MBA
  • Telefonnummer: +573016348173
  • E-post: acardona@fctic.org

Studiesteder

  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110131
        • Rekruttering
        • Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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).
Diagnostisk test: 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).
Diagnostisk test: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sensitivity of the Methylscape test for cancer-signal detection, as assessed against histopathological confirmation as the reference standard
Tidsramme: 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
Tidsramme: 12 months
Percentage of confirmed cancer-free volunteers who have a negative Methylscape result (no cancer signal detected).
12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Positive and negative predictive value (PPV and NPV) of Methylscape for cancer-signal detection
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. juni 2025

Primær fullføring (Antatt)

4. juni 2027

Studiet fullført (Antatt)

15. januar 2028

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

28. juli 2026

Først lagt ut (Faktiske)

3. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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