Gastric CancerATLASNCT07676461
Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy
An observational study of Gastric Cancer and Colorectal Cancer, run by Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Colorectal Cancer, Breast Cancer
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteColombia
- Study dates
- 11 Jun 2026to 30 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogotá, Bogota D.C., 110131
Liliana Gutiérrez, RN, MSc, +573003768158, lgutierrez@fctic.org
Andrés F Cardona, MD, MSc, PhD, MBA
About this study
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
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.
Read the 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.
- Conditions
- Gastric Cancer, Colorectal Cancer, Breast Cancer, Cervical Cancer, Head and Neck Cancer (H&N)
- Being tested
- First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of care
- Keywords
- Microbiome, Cancer, Immunotherapy, Tumor microenvironment, Biomarkers, Metagenomics, Transcriptomics, Metabolomics
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms, Breast Neoplasms, Uterine Cervical Neoplasms, Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of careDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (V0)
Secondary outcomes (2)
Microbial, transcriptomic and metabolomic biomarkers associated with progression-free survival (PFS)
Up to 36 months
Measured: 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)
Association of microbiome features with overall survival, estimated by Kaplan-Meier and adjusted Cox models.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start11 Jun 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Responsible party
- Sponsor
- Investigators
- Andrés F Cardona, MD, MSc, PhD, MBA, Principal investigator, Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676461
- Sponsor's protocol ID
- ATLAS
- Other IDs
- CEI-232
- Acronym
- ATLAS
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified genomic sequences (oral, fecal and intratumoral microbiome) will be deposited in public repositories (NCBI SRA / EBI ENA) with minimal metadata (tumor type, age by decade, sex). Analysis pipelines and code will be versioned and shared via GitHub and Zenodo. Raw data and code will be made public at study close.
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.
PubMed 32019901Zhernakova 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.
PubMed 27126040Dohlman 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.
PubMed 33382980Parida 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.
PubMed 33148661Park 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.
PubMed 35440726Cullin 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.
PubMed 34506740El 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.
PubMed 37400581Parizadeh 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.
PubMed 37516570Govender 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.
PubMed 39244168Trakman 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.
PubMed 34716949
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07676461
- Acronym / sponsor ID
- ATLAS / ATLAS
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento AnguloUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced solid tumors | – | Drug: First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of care120 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of careExposure 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. | Drug | Patients with advanced solid tumors |
Primary outcome
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
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.
Differences in microbiome composition and diversity between cancer patients and healthy controls
Time frame: Baseline (V0)
Comparison of alpha and beta diversity and differential taxonomic and functional abundance between cancer patients and healthy controls.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 32019901Mancini 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.
- Background: PubMed 27126040Zhernakova 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.
- Background: PubMed 33382980Dohlman 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.
- Background: PubMed 33148661Parida 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.
- Background: PubMed 35440726Park 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.
- Background: PubMed 34506740Cullin 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.
- Background: PubMed 37400581El 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.
- Background: PubMed 37516570Parizadeh 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.
- Background: PubMed 39244168Govender 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.
- Background: PubMed 34716949Trakman 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.
- Individual participant dataSharing planned: Yes. De-identified genomic sequences (oral, fecal and intratumoral microbiome) will be deposited in public repositories (NCBI SRA / EBI ENA) with minimal metadata (tumor type, age by decade, sex). Analysis pipelines and code will be versioned and shared via GitHub and Zenodo. Raw data and code will be made public at study close.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrés F Cardona, MD, MSc, PhD, MBA principal investigator
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Colorectal Cancer, run by Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrés F Cardona, MD, MSc, PhD, MBA (+573016348173, acardona@fctic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07676461, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.