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

ConditionsNeoplasmsSolid TumorBreast NeoplasmsLung NeoplasmsStomach NeoplasmsUterine Cervical NeoplasmsColorectal NeoplasmsUrologic NeoplasmsHead and Neck NeoplasmsEarly Detection of CancerNeoplasm Recurrence, Local
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Methylscape DNA methylation assay

    Diagnostic test

    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.

Treatment groups

3,250 Participants
are divided into 2 treatment groups
Group A: Patients with cancer1 intervention
Group B: Cancer-free (healthy) volunteers1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of the Methylscape test for cancer-signal detection, as assessed against histopathological confirmation as the reference standard

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.

Time frame
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

Percentage of confirmed cancer-free volunteers who have a negative Methylscape result (no cancer signal detected).

Time frame
12 months

Secondary outcomes

1

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

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).

Time frame
Baseline
2

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

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.

Time frame
At 6, 12, 18, and 24 months

Other outcomes

1

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

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.

Time frame
Up to 12 months
2

Diagnostic performance of Methylscape in cancers with versus without established screening programs

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).

Time frame
Up to 12 months
3

Budget impact of implementing Methylscape as a multi-cancer early detection strategy

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.

Time frame
Through study completion, an average of 24 months
4

Cost-effectiveness of Methylscape (incremental cost-effectiveness ratio)

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.

Time frame
Through study completion, an average of 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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