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RECRUITING
NCT07676461

Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy

Sponsor: Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-06-11

Completion Date

2029-08-30

Last Updated

2026-07-07

Healthy Volunteers

Yes

Interventions

DRUG

First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of care

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.

Locations (1)

Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

Bogotá, Bogota D.C., Colombia