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

NCT07676461 | Recruiting

• 2 other identifiers: ATLASCEI-232
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer; Colorectal Cancer; Breast Cancer; Cervical Cancer; Head and Neck Cancer (H&N)

Keywords

Microbiome; Cancer; Immunotherapy; Tumor microenvironment; Biomarkers; Metagenomics; Transcriptomics; Metabolomics

Outcome Measures

Primary Outcomes (2)

• Oral, fecal and intratumoral microbiome signatures associated with objective tumor response (RECIST 1.1) to first-line immunotherapy

  Characterization of oral, fecal and intratumoral microbiomes and identification of taxa and diversity metrics differentiating responders (CR+PR) from non-responders (SD+PD) by RECIST 1.1.

  Baseline (V0) and through 12 months

• Differences in microbiome composition and diversity between cancer patients and healthy controls

  Comparison of alpha and beta diversity and differential taxonomic and functional abundance between cancer patients and healthy controls.

  Baseline (V0)

Secondary Outcomes (2)

• Microbial, transcriptomic and metabolomic biomarkers associated with progression-free survival (PFS)

  Association of microbial diversity, key taxa, MAGs and functional pathways with progression-free survival, estimated by Kaplan-Meier and adjusted Cox models.

• Microbial biomarkers associated with overall survival (OS)

  Up to 36 months

Other Outcomes (2)

• Tumor transcriptomic profile and gene-expression pathways modulated by the intratumoral microbiome

  Baseline (V0)

• Untargeted salivary and fecal metabolomic profile (subcohort, n=60)

  Baseline through 12 months

Study Arms (2)

Patients with advanced solid tumors

120 Colombian adults with advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer, candidates for first-line immunotherapy (standard of care). Saliva, stool and tongue scraping collected at V0, V1 (6 mo) and V2 (12 mo); archival FFPE tumor block retrieved at V0.

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

Healthy controls

30 healthy adult volunteers without prior cancer, active autoimmune disease or inflammatory bowel disease, and without antibiotics or invasive dental treatment in the prior 3 months. Saliva and stool collected at V0 only; no longitudinal follow-up.

Interventions

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

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.

Patients with advanced solid tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical, head-and-neck) candidates for first-line immunotherapy, plus healthy adult volunteers. Single center: Fundación CTIC, Bogotá.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo: lead
• American Society of Clinical Oncology: collaborator

Study Sites (1)

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

Bogotá, Bogota D.C., 110131, Colombia

RECRUITING

Related Publications (10)

• Mancini N, Peri F, Rescigno M, Zanoni I. Microbiome studies in the medical sciences and the need for closer multidisciplinary interplay. Sci Signal. 2020 Feb 4;13(617):eaba9911. doi: 10.1126/scisignal.aba9911.

  PMID: 32019901 BACKGROUND

• Zhernakova A, Kurilshikov A, Bonder MJ, Tigchelaar EF, Schirmer M, Vatanen T, Mujagic Z, Vila AV, Falony G, Vieira-Silva S, Wang J, Imhann F, Brandsma E, Jankipersadsing SA, Joossens M, Cenit MC, Deelen P, Swertz MA; LifeLines cohort study; Weersma RK, Feskens EJ, Netea MG, Gevers D, Jonkers D, Franke L, Aulchenko YS, Huttenhower C, Raes J, Hofker MH, Xavier RJ, Wijmenga C, Fu J. Population-based metagenomics analysis reveals markers for gut microbiome composition and diversity. Science. 2016 Apr 29;352(6285):565-9. doi: 10.1126/science.aad3369. Epub 2016 Apr 28.

  PMID: 27126040 BACKGROUND

• Dohlman AB, Arguijo Mendoza D, Ding S, Gao M, Dressman H, Iliev ID, Lipkin SM, Shen X. The cancer microbiome atlas: a pan-cancer comparative analysis to distinguish tissue-resident microbiota from contaminants. Cell Host Microbe. 2021 Feb 10;29(2):281-298.e5. doi: 10.1016/j.chom.2020.12.001. Epub 2021 Jan 6.

  PMID: 33382980 BACKGROUND

• Parida S, Sharma D. The Microbiome and Cancer: Creating Friendly Neighborhoods and Removing the Foes Within. Cancer Res. 2021 Feb 15;81(4):790-800. doi: 10.1158/0008-5472.CAN-20-2629. Epub 2020 Nov 4.

  PMID: 33148661 BACKGROUND

• Park EM, Chelvanambi M, Bhutiani N, Kroemer G, Zitvogel L, Wargo JA. Targeting the gut and tumor microbiota in cancer. Nat Med. 2022 Apr;28(4):690-703. doi: 10.1038/s41591-022-01779-2. Epub 2022 Apr 19.

  PMID: 35440726 BACKGROUND

• Cullin N, Azevedo Antunes C, Straussman R, Stein-Thoeringer CK, Elinav E. Microbiome and cancer. Cancer Cell. 2021 Oct 11;39(10):1317-1341. doi: 10.1016/j.ccell.2021.08.006. Epub 2021 Sep 9.

  PMID: 34506740 BACKGROUND

• El Tekle G, Garrett WS. Bacteria in cancer initiation, promotion and progression. Nat Rev Cancer. 2023 Sep;23(9):600-618. doi: 10.1038/s41568-023-00594-2. Epub 2023 Jul 3.

  PMID: 37400581 BACKGROUND

• Parizadeh M, Arrieta MC. The global human gut microbiome: genes, lifestyles, and diet. Trends Mol Med. 2023 Oct;29(10):789-801. doi: 10.1016/j.molmed.2023.07.002. Epub 2023 Jul 27.

  PMID: 37516570 BACKGROUND

• Govender P, Ghai M. Population-specific differences in the human microbiome: Factors defining the diversity. Gene. 2025 Jan 15;933:148923. doi: 10.1016/j.gene.2024.148923. Epub 2024 Sep 6.

  PMID: 39244168 BACKGROUND

• Trakman GL, Fehily S, Basnayake C, Hamilton AL, Russell E, Wilson-O'Brien A, Kamm MA. Diet and gut microbiome in gastrointestinal disease. J Gastroenterol Hepatol. 2022 Feb;37(2):237-245. doi: 10.1111/jgh.15728. Epub 2021 Nov 16.

  PMID: 34716949 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, stool (feces) and tongue scraping (lingual swab), plus archival FFPE tumor tissue. DNA, RNA and metabolite aliquots stored at -80°C in the institutional biobank (EVA-BIOBANCO) for up to 10 years; FFPE blocks in the institutional pathology archive. Samples retained with DNA for approved future research.

MeSH Terms

Conditions

Stomach Neoplasms; Colorectal Neoplasms; Breast Neoplasms; Uterine Cervical Neoplasms; Head and Neck Neoplasms; Neoplasms

Interventions

Immune Checkpoint Inhibitors; Standard of Care

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Andrés F Cardona, MD, MSc, PhD, MBA

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrés F Cardona, MD, MSc, PhD, MBA

CONTACT

+573016348173; acardona@fctic.org

Liliana Gutiérrez, RN, MSc

CONTACT

+573003768158; lgutierrez@fctic.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): August 30, 2029
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Available at study close (estimated 2029); retained at least 15 years per ICH-GCP archiving policy.
• Access Criteria: Open access via public repositories (SRA, ENA, Zenodo) for de-identified sequence data and analysis code.

Locations

CO (1)