About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Systemic antibiotics within 3 months (except short course under 5 days for uncomplicated infection).
Probiotics or prebiotics within 30 days.
Chronic proton-pump inhibitors for more than 3 continuous months.
Inflammatory bowel disease (Crohn, ulcerative colitis) or extensive bowel resection.
Trial design
Treatments tested in this trial
- First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of care
Treatment groups
Sponsors and collaborators
Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
Lead sponsor
American Society of Clinical Oncology
Collaborator
Asociación Colombiana de Hematología y Oncología ACHO
Collaborator