[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649958":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":10,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":80,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with cancer",null,"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\u002Furine sampling for relapse detection (Sub-study 2b).",[13],"Diagnostic Test: Methylscape DNA methylation assay",{"label":15,"type":10,"description":16,"interventionNames":17},"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\u002Fethnicity, and BMI. Provide blood, urine, and saliva for Methylscape testing (Sub-study 2a).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Methylscape DNA methylation assay","Rapid assay measuring global DNA methylation patterns in body fluids (blood\u002Fplasma, 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.",[15,9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Andrés Cardona, MD, MSc, PhD, MBA","CONTACT","+573016348173","acardona@fctic.org",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo","RECRUITING","Bogotá","Bogota D.C.","110131","Colombia","CO",{"type":40,"coordinates":41},"Point",[42,43],-74.08175,4.60971,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":48,"phoneExt":10,"email":49},"Liliana Gutiérrez Babativa, RN, MSc","+573003768158","lgutierrez@fctic.org",{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100649958","methylation-profile-test-methylscape-in-body-fluids-for-multi-cancer-detection-and-monitoring-in-colombia-100649958",false,"NCT07741435","Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia","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","METHYLSCAPE-CO","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Willing and able to participate and to provide the required samples (blood, urine, saliva) and demographic information (age, sex, race\u002Fethnicity, BMI).\n* Able to provide written informed consent for participation and for use of biological samples. For CTIC Biobank samples, prior research-use consent is verified.\n* Demographic\u002Fanthropometric comparability (race, ethnicity, BMI) with other participants; race\u002Fethnicity by self-identification (WHO and national census categories); BMI per WHO categories.\n\nInclusion - Cancer cohort:\n\n* Cancer diagnosis confirmed within 90 days prior to sample collection.\n* Biopsy-proven malignancy with radiological staging.\n* No anticancer treatment at the time of collection or within the previous 3 years.\n* Inclusion - Cancer-free (healthy) cohort:\n* No cancer diagnosis or treatment in the previous 3 years (ICD-O-3 behavior code 2 or 3).\n* Not under evaluation for suspected cancer (verified by medical record review or additional medical evaluation).\n* 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.\n\nAdditional criteria - tumor-burden monitoring (Sub-study 2b):\n\n* Biopsy-confirmed cancer.\n* ECOG performance status ≤ 2.\n\nExclusion Criteria (both cohorts):\n\n* Failure to meet the general or cohort-specific inclusion criteria.\n* Pregnancy.\n* Organ transplant recipients.\n* Use of demethylating agents (azacitidine, decitabine) or cytotoxic agents (including for autoimmune\u002Finflammatory conditions).\n* 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.",true,"ALL","18 Years",{"count":64,"type":65},3250,"ESTIMATED","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.\n\nThis 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.\n\nThe study also estimates positive and negative predictive values (PPV\u002FNPV) 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.",[69,70,71,72,73,74,75,76,77,78,79],"Neoplasms","Solid Tumor","Breast Neoplasms","Lung Neoplasms","Stomach Neoplasms","Uterine Cervical Neoplasms","Colorectal Neoplasms","Urologic Neoplasms","Head and Neck Neoplasms","Early Detection of Cancer","Neoplasm Recurrence, Local",[81,82,83,84,85,86,87,88,89,37],"DNA methylation","Liquid biopsy","Cell-free DNA (cfDNA)","Multi-cancer early detection (MCED)","Methylscape","Cancer signal origin","Minimal residual disease","Methylation biomarker","Cancer screening","2026-07-28",{"date":92,"type":93},"2026-08-03","ACTUAL",{"date":95,"type":93},"2025-06-05",{"date":97,"type":65},"2028-01-15",{"name":5,"class":6},1]