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.
• 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.