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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

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

150 Participants
are divided into 2 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