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Recruiting NCT07676461

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

— Observational Gastric Cancer Colorectal Cancer Breast Cancer Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of care.
Who it may be relevant to
Registry conditions: Gastric Cancer, Colorectal Cancer, Breast Cancer, Cervical Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Colombia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

Single-center, prospective, observational cohort study. 120 patients with advanced (stage III unresectable or IV) solid tumors candidates for first-line immunotherapy and 30 healthy controls are enrolled (total N=150). Patients provide saliva, stool and tongue-scraping samples plus archival FFPE tumor tissue at baseline (V0) and at 6 (V1) and 12 (V2) months; controls provide saliva and stool at V0 only. Microbiomes are profiled by PacBio HiFi shotgun metagenomics and full-length 16S; tumor transcriptome by RNA-Seq; and saliva/stool metabolome by GC-MS in a subcohort (n=60). Tumor response is assessed by RECIST 1.1. Microbial, transcriptomic and metabolomic features are integrated with clinical outcomes (objective response, PFS, OS) using multivariable and machine-learning models.

Interventions

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

Primary outcome measures

  • Oral, fecal and intratumoral microbiome signatures associated with objective tumor response (RECIST 1.1) to first-line immunotherapy [Time frame: Baseline (V0) and through 12 months]
  • Differences in microbiome composition and diversity between cancer patients and healthy controls [Time frame: Baseline (V0)]
Secondary outcome measures (2)
  • Microbial, transcriptomic and metabolomic biomarkers associated with progression-free survival (PFS) [Time frame: 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) [Time frame: Up to 36 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Colombia · 1 center
  • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento — Bogotá

Publications

  • 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
  • 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 PMID 27126040
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07676461 · ATLAS · CEI-232

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗