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.
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.
Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical, head-and-neck) candidates for first-line immunotherapy, plus healthy adult volunteers. Single center: Fundación CTIC, Bogotá.
Cohort
Prospective
First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of care
DrugExposure 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.
Oral, fecal and intratumoral microbiome signatures associated with objective tumor response (RECIST 1.1) to first-line immunotherapy
Characterization of oral, fecal and intratumoral microbiomes and identification of taxa and diversity metrics differentiating responders (CR+PR) from non-responders (SD+PD) by RECIST 1.1.
Differences in microbiome composition and diversity between cancer patients and healthy controls
Comparison of alpha and beta diversity and differential taxonomic and functional abundance between cancer patients and healthy controls.
Microbial, transcriptomic and metabolomic biomarkers associated with progression-free survival (PFS)
Up to 36 months
Microbial biomarkers associated with overall survival (OS)
Association of microbiome features with overall survival, estimated by Kaplan-Meier and adjusted Cox models.
Tumor transcriptomic profile and gene-expression pathways modulated by the intratumoral microbiome
RNA-Seq characterization of tumor gene-expression and identification of pathways correlated with intratumoral microbiome composition.
Untargeted salivary and fecal metabolomic profile (subcohort, n=60)
GC-MS untargeted metabolomics of saliva and stool in a stratified subcohort (50 patients, 10 controls) to identify metabolites associated with microbiome composition and immunotherapy response.
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Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
Lead sponsor
American Society of Clinical Oncology
Collaborator
