NCT07676461Recruiting
Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy
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
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 24 Jun 2026
- Start date
- 11 Jun 2026
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
- NCT number
- NCT07676461
What you commit to
- Study type: Observational
- Planned participants: 150
- From 11 Jun 2026 to the primary completion date, 28 Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic proton-pump inhibitors for more than 3 continuous months.
- Patients: simultaneous randomized trial of a non-INVIMA-approved experimental immunotherapy; or no evaluable FFPE block meeting quality thresholds.
Other illness
- Systemic antibiotics within 3 months (except short course under 5 days for uncomplicated infection).
- Inflammatory bowel disease (Crohn, ulcerative colitis) or extensive bowel resection.
Lab values
- Uncontrolled diabetes (HbA1c at or above 9% in prior 3 months).
Other
- Probiotics or prebiotics within 30 days.
- Pregnancy or lactation.
- BMI under 18.5 or over 40 kg/m².
- Invasive dental treatment within 3 months.
- Inability to ensure 12-month clinical follow-up.
Who the study is looking for
- 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.
- Able to provide saliva and stool samples at V0 and follow-up.
- ECOG performance status within protocol limits; life expectancy over 3 months.
- Cognitive capacity to give informed consent; signed EVA-BIOBANCO and Atlas consents.
- No prior cancer diagnosis.
- No active autoimmune disease; no inflammatory bowel disease.
- No antibiotics, invasive dental treatment, immunosuppressants or corticosteroids in the prior 3 months; no severe active periodontal disease.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo Coordinator of this site? Confirm its status | Bogotá | Colombia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.