[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644983":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":28,"locations":37,"responsibleParty":54,"collaborators":56,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":10,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":84,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"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 advanced solid tumors",null,"120 Colombian adults with advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer, candidates for first-line immunotherapy (standard of care). Saliva, stool and tongue scraping collected at V0, V1 (6 mo) and V2 (12 mo); archival FFPE tumor block retrieved at V0.",[13],"Drug: First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of care",{"label":15,"type":10,"description":16,"interventionNames":10},"Healthy controls","30 healthy adult volunteers without prior cancer, active autoimmune disease or inflammatory bowel disease, and without antibiotics or invasive dental treatment in the prior 3 months. Saliva and stool collected at V0 only; no longitudinal follow-up.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DRUG","First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of care","Exposure observed: first-line immunotherapy with immune checkpoint inhibitors administered as standard of care (INVIMA-approved); no experimental intervention is assigned by the study. Healthy controls receive no immunotherapy.",[9],[24],{"name":25,"affiliation":26,"role":27},"Andrés F Cardona, MD, MSc, PhD, MBA","Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo","PRINCIPAL_INVESTIGATOR",[29,33],{"name":25,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","+573016348173","acardona@fctic.org",{"name":34,"role":30,"phone":35,"phoneExt":10,"email":36},"Liliana Gutiérrez, RN, MSc","+573003768158","lgutierrez@fctic.org",[38],{"facility":26,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Bogotá","Bogota D.C.","110131","Colombia","CO",{"type":46,"coordinates":47},"Point",[48,49],-74.08175,4.60971,{"lat":49,"lon":48},[52,53],{"name":34,"role":30,"phone":35,"phoneExt":10,"email":36},{"name":25,"role":27,"phone":10,"phoneExt":10,"email":10},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57,59],{"name":58,"class":6},"American Society of Clinical Oncology",{"name":60,"class":61},"Asociación Colombiana de Hematología y Oncología ACHO","UNKNOWN","100644983","oral-fecal-and-intratumoral-microbiome-atlas-in-colombian-patients-with-advanced-solid-tumors-receiving-first-line-immunotherapy-100644983",false,"NCT07676461","Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy","Atlas of the Oral, Fecal and Intratumoral Microbiome of Colombian Patients With Advanced Solid Tumors Candidates for First-Line Immunotherapy - Initial Phase of a Project With Latin American Projection","ATLAS","Inclusion Criteria:\n\n* Age 18 years or older.\n* Histologically confirmed advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer.\n* Candidate for first-line immunotherapy per current clinical guidelines.\n* Available FFPE tumor block in institutional or reference pathology archive.\n* Able to provide saliva and stool samples at V0 and follow-up.\n* ECOG performance status within protocol limits; life expectancy over 3 months.\n* Cognitive capacity to give informed consent; signed EVA-BIOBANCO and Atlas consents.\n\nInclusion Criteria (healthy controls)\n\n* No prior cancer diagnosis.\n* No active autoimmune disease; no inflammatory bowel disease.\n* No antibiotics, invasive dental treatment, immunosuppressants or corticosteroids in the prior 3 months; no severe active periodontal disease.\n\nExclusion Criteria:\n\n* Systemic antibiotics within 3 months (except short course under 5 days for uncomplicated infection).\n* Probiotics or prebiotics within 30 days.\n* Chronic proton-pump inhibitors for more than 3 continuous months.\n* Inflammatory bowel disease (Crohn, ulcerative colitis) or extensive bowel resection.\n* Pregnancy or lactation.\n* BMI under 18.5 or over 40 kg\u002Fm².\n* Uncontrolled diabetes (HbA1c at or above 9% in prior 3 months).\n* Invasive dental treatment within 3 months.\n* Patients: simultaneous randomized trial of a non-INVIMA-approved experimental immunotherapy; or no evaluable FFPE block meeting quality thresholds.\n* Inability to ensure 12-month clinical follow-up.",true,"ALL","18 Years",{"count":74,"type":75},150,"ESTIMATED","OBSERVATIONAL","This is a prospective observational cohort study conducted at Fundación CTIC in Bogotá, Colombia. It characterizes the oral, fecal and intratumoral microbiome of Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical and head-and-neck cancer) who receive first-line immunotherapy as standard of care, and compares them with healthy volunteers. Using multi-omics (HiFi metagenomics, 16S, tumor RNA-Seq and untargeted metabolomics), the study aims to identify microbial signatures associated with treatment response and survival, building the initial Colombian cohort of a Cancer Microbiome Atlas with Latin American projection.",[79,80,81,82,83],"Gastric Cancer","Colorectal Cancer","Breast Cancer","Cervical Cancer","Head and Neck Cancer (H&N)",[85,86,87,88,89,90,91,92],"Microbiome","Cancer","Immunotherapy","Tumor microenvironment","Biomarkers","Metagenomics","Transcriptomics","Metabolomics","2026-06-24",{"date":95,"type":96},"2026-06-30","ACTUAL",{"date":98,"type":96},"2026-06-11",{"date":100,"type":75},"2029-08-30",{"name":5,"class":6},1]