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Development and Analysis of a Stool Bank for Cancer Patients
NCT04291755 · View on ClinicalTrials.gov ↗
Study Summary
This study is aimed at understanding the impact of gut microbiota on efficacy of cancer therapies, in particular checkpoint inhibitors, and using the resulting information to design microbial immunotherapies. Although animal models are of use to determine the influences of gut and other microbiota on cancer treatment modalities, they are limited due to differences between mouse and human physiology and immunology, as well as the inherent differences in gut microbial populations between the two mammalian organisms. Therefore, samples obtained as donations from human subjects undergoing cancer treatment are of great value for the identification and determination of bacteria and their metabolic processes that are involved in the successful cure and remission of cancer by checkpoint inhibitor therapies. The objective of this study is to collect 3 samples each of blood, urine, and stool in subjects with cancer. This is a non-interventional, 2 site study in 100 people who are undergoing any type of cancer immunotherapy. Subjects who meet the entry criteria will provide 5 samples each of blood, urine, and stool over a 12-month period.
Conditions Studied
Interventions
- DRUG Pembrolizumab Injection
Study Locations (2)
California
- Compassionate Care Research Group, Inc. — Fountain Valley
Florida
- Bond and Steele Clinic, P.A. — Winter Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-06-28 |
| Est. Completion | 2028-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04291755
The ClinicalTrials.gov registry entry for NCT04291755 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Persephone Biosciences, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Carcinoma, Non-Small-Cell Lung appearing as the primary indexed condition, and to 1 intervention — of which Pembrolizumab Injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04291755 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04291755 about?
NCT04291755 is a clinical study titled "Development and Analysis of a Stool Bank for Cancer Patients". This study is aimed at understanding the impact of gut microbiota on efficacy of cancer therapies, in particular checkpoint inhibitors, and using the resulting information to design microbial immunotherapies. Although animal models are of use to determine the influences of gut and other microbiota o...
What is the current status of trial NCT04291755?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2019-06-28. Estimated completion is 2028-12-31.
What conditions does trial NCT04291755 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04291755?
The interventions under investigation include: Pembrolizumab Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04291755?
This trial is sponsored by Persephone Biosciences, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04291755 being conducted?
This trial has 2 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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