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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective observational cohort enrolling 120 patients with advanced gastric, colorectal, breast, cervical, or head-and-neck cancers and 30 healthy controls. Participants provide saliva, stool, tongue-scrape, and archival tumor tissue at baseline and after 6 and 12 months, with controls providing samples at baseline. Microbial profiles are generated using HiFi shotgun metagenomics and full-length 16S, tumor RNA-Seq, and metabolomics in a subset, and outcomes are linked to RECIST responses, progression-free survival, and overall survival using multivariable and machine-learning approaches.

Why it matters

Who can join: the full rules

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 ensure 12-month clinical follow-up.

Where it's running

• Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
  Bogotá, Bogota D.C., Colombia Recruiting

Study contacts

• Principal investigator: Andrés F Cardona, MD, MSc, PhD, MBA — Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
• Study coordinator: Andrés F Cardona, MD, MSc, PhD, MBA
• Email: acardona@fctic.org
• Phone: +573016348173

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Guaraná Supplement for Cancer-Related Fatigue in People Undergoing Treatment

  This study tests whether taking guaraná capsules helps reduce cancer-related fatigue and improve quality of life in adults with breast, lung, colorectal, or gastric cancer who are actively receiving treatment.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07816263

• Testing MGC026 in patients with advanced solid tumors

  This study is testing a new treatment called MGC026 to see if it can help adults with advanced solid tumors that can't be removed or have spread to other parts of the body.

  Recruiting at 12 sites Phase 1 MacroGenics · Los Angeles, California and 11 other locations · NCT06242470

• Combination therapy using checkpoint inhibitors for advanced solid tumors

  This study is testing a new combination treatment using special antibodies for people with advanced solid tumors like lung and liver cancer to see if it can be safer and more effective than current options.

  Recruiting Phase 1/2 Second Affiliated Hospital of Guangzhou Medical University · Guangzhou, Guangdong · NCT05187338

• First-in-human STRO-006 in adults with certain recurrent or metastatic solid tumors

  This study tests STRO-006 alone and with pembrolizumab in adults with certain head and neck, lung, esophageal, gastric, colorectal cancers to see if it is safe and shows early anticancer activity.

  Recruiting at 3 sites Phase 1 Sutro Biopharma, Inc. · Orlando, Florida and 5 other locations · NCT07807345

• CAIX-targeted 18F-T2 PET/CT imaging in solid tumors

  This study tests a CAIX-specific radioactive tracer to see if PET/CT can help visualize solid tumors and checks safety and radiation exposure in adults with certain cancers.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07557225

• STRO-004 treatment in adults with recurrent or metastatic solid tumors

  This study will test whether STRO-004, alone and with pembrolizumab, is safe and can shrink tumors in adults with several types of metastatic cancers that often express Tissue Factor.

  Recruiting at 9 sites Phase 1 Sutro Biopharma, Inc. · San Diego, California and 8 other locations · NCT07227168

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.