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.
Single-center, prospective, observational cohort study. 120 patients with advanced (stage III unresectable or IV) solid tumors candidates for first-line immunotherapy and 30 healthy controls are enrolled (total N=150). Patients provide saliva, stool and tongue-scraping samples plus archival FFPE tumor tissue at baseline (V0) and at 6 (V1) and 12 (V2) months; controls provide saliva and stool at V0 only. Microbiomes are profiled by PacBio HiFi shotgun metagenomics and full-length 16S; tumor transcriptome by RNA-Seq; and saliva/stool metabolome by GC-MS in a subcohort (n=60). Tumor response is assessed by RECIST 1.1. Microbial, transcriptomic and metabolomic features are integrated with clinical outcomes (objective response, PFS, OS) using multivariable and machine-learning models.
Study Type
OBSERVATIONAL
Enrollment
150
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.
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogotá, Bogota D.C., Colombia
RECRUITINGOral, 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.
Time frame: Baseline (V0) and through 12 months
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.
Time frame: Baseline (V0)
Microbial, transcriptomic and metabolomic biomarkers associated with progression-free survival (PFS)
Up to 36 months
Time frame: Association of microbial diversity, key taxa, MAGs and functional pathways with progression-free survival, estimated by Kaplan-Meier and adjusted Cox models.
Microbial biomarkers associated with overall survival (OS)
Association of microbiome features with overall survival, estimated by Kaplan-Meier and adjusted Cox models.
Time frame: Up to 36 months
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