Gut, Mouth and Tumor Bacteria in Colombian Adults With Advanced Cancer
Studies microbes in the mouth, stool and tumors of adults on immunotherapy.
Plain-language title generated from the registry record
Registry title: Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy
Key facts
- Where
- Bogotá, ColombiaSee the site
Where in Colombia
- Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento AnguloBogotá, ColombiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
- Trial code
- NCT07676461
- Record updated
- 7 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age 18 years or older; Histologically confirmed advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer; Candidate for first-line immunotherapy per current clinical guidelines; Available FFPE tumor block in institutional or reference pathology archive; Able to provide saliva and stool samples at V0 and follow-up; ECOG performance status within protocol limits; life expectancy over 3 months; Cognitive capacity to give informed consent; signed EVA-BIOBANCO and Atlas consents; No prior cancer diagnosis; No active autoimmune disease; no inflammatory bowel disease; No antibiotics, invasive dental treatment, immunosuppressants or corticosteroids in the prior 3 months; no severe active periodontal disease.
Exclusion: Chronic proton-pump inhibitors for more than 3 continuous months; Patients: simultaneous randomized trial of a non-INVIMA-approved experimental immunotherapy; or no evaluable FFPE block meeting quality thresholds; Systemic antibiotics within 3 months (except short course under 5 days for uncomplicated infection); Inflammatory bowel disease (Crohn, ulcerative colitis) or extensive bowel resection; Uncontrolled diabetes (HbA1c at or above 9% in prior 3 months); Probiotics or prebiotics within 30 days; Pregnancy or lactation; BMI under 18.5 or over 40 kg/m²; Invasive dental treatment within 3 months; Inability to ensure 12-month clinical follow-up.