Clinical trial · Observational
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
NCT07676461CI-TRIAL-00117158ATLASrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer (H&N) | Malignant Head and Neck Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of care | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients with advanced solid tumors
- description
- 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.
- interventionNames
- Drug: First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of care
- label
- Healthy controls
- description
- 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.
Primary outcomes (2)
- measure
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDMancini 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
- BACKGROUNDZhernakova 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
- BACKGROUNDDohlman 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
- BACKGROUNDParida 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
- BACKGROUNDPark 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
- BACKGROUNDCullin 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.