NCT05037825Recruiting
The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
Source: ClinicalTrials.gov · Last updated 27 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy. Additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses. However, large prospective studies in humans with longitudinal sample collection and standardized methods are needed to understand how microbiota and their byproducts affect cancer therapies, particularly among patients undergoing identical therapy but experiencing different outcomes. The proposed observational study builds upon these hypotheses by proposing a large cohort design to further assess the associations between the gut microbiota (composition and function), host immune system, and ICI treatment efficacy across multiple cancer types.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 2 Aug 2021
- Start date
- 22 Nov 2021
- Primary completion date
- 14 Sept 2023
- Lead sponsor
- VastBiome
- NCT number
- NCT05037825
What you commit to
- Study type: Observational
- Planned participants: 800
- From 22 Nov 2021 to the primary completion date, 14 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with checkpoint inhibitor in off-label capacity or through a clinical/interventional trial
Other
- Mental incapacity
- Incarcerated individuals
- Pregnancy (by self-report of pregnancy status)
- Experiencing active brain metastasis/metastases
- Active participation in an immuno-oncology clinical/interventional trial or pharma-sponsored observational study
Who the study is looking for
- Men or women ≥18 years of age
- Screened negative for COVID-19 symptoms at time of consent, as per institutional policy and as applicable for the duration of the COVID-19 pandemic
- Diagnosed with stages I-IV primary NSCLC, MM, TNBC or RCC
- Plan to be treated at a partner cancer site with a checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti-CTLA-4) as a single agent or in combination with another checkpoint inhibitor or other treatment agent or modality (e.g., targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with FDA-labeled use of the agent
- Able to provide informed consent and answer study questionnaires in either English or Spanish
- Able to provide stool specimens for research purposes
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baptist Health Clinical Research Coordinator of this site? Confirm its status | Elizabethtown | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.