An observational study in Neoplasms, Solid Tumor and Breast Neoplasms, sponsored by Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo. Recruiting at 1 site in Colombia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Observational
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 3,250 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
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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.
Inclusion Criteria:
Inclusion - Cancer cohort:
Additional criteria - tumor-burden monitoring (Sub-study 2b):
Exclusion Criteria (both cohorts):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Diagnostic Test: Methylscape DNA methylation assay
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).
Diagnostic 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.
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
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
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
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
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
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
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
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
Plan to share: Yes — 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
Supporting information: Clinical study report
Time frame: 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.
Access criteria: 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.
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Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo