Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Re… (NCT07676461) | Clinical Trial Compass
RecruitingNot Applicable
Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy
Colombia150 participantsStarted 2026-06-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Inclusion Criteria (healthy controls)
* 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.
Exclusion Criteria:
* 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.
* Pregnancy or lactation.
* BMI under 18.5 or over 40 kg/m².
* Uncontrolled diabetes (HbA1c at or above 9% in prior 3 months).
* Invasive dental treatment within 3 months.
* Patients: simultaneous randomized trial of a non-INVIMA-approved experimental immunotherapy; or no evaluable FFPE block meeting quality thresholds.
* Inability to ensu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oral, fecal and intratumoral microbiome signatures associated with objective tumor response (RECIST 1.1) to first-line immunotherapy
Timeframe: Baseline (V0) and through 12 months
2
Differences in microbiome composition and diversity between cancer patients and healthy controls
Timeframe: Baseline (V0)
Trial details
NCT IDNCT07676461
SponsorCentro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo