Actively Recruiting
The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
Led by VastBiome · Updated on 2022-04-27
800
Participants Needed
1
Research Sites
355 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women 18 years of age or older
- Screened negative for COVID-19 symptoms at time of consent and as applicable during the pandemic
- Diagnosed with stages I-IV primary non-small-cell lung carcinoma, malignant melanoma, triple-negative breast cancer, or renal cell carcinoma
- Planning treatment at a partner cancer site with checkpoint inhibitors (anti-PD-1, anti-PD-L1, or anti-CTLA-4) alone or combined with other therapies per FDA-approved use
- Able to provide informed consent and complete study questionnaires in English or Spanish
- Able to provide stool specimens for research purposes
You will not qualify if you...
- Mental incapacity
- Incarcerated individuals
- Pregnancy by self-report
- Active brain metastases
- Treatment with checkpoint inhibitors outside FDA-labeled use or through other clinical/interventional trials
- Participation in other immuno-oncology clinical/interventional trials or pharmaceutical-sponsored observational studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Baptist Health Clinical Research
Elizabethtown, Kentucky, United States, 42701
Actively Recruiting
Research Team
H
Hanane Arib, MS
CONTACT
P
Peter McCaffrey, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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