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NCT04291755 · ClinicalTrials.gov registry record
Development and Analysis of a Stool Bank for Cancer Patients
A clinical trial of Carcinoma, Non-Small Cell Lung and Carcinoma, Colorectal, sponsored by Persephone Biosciences.
- Recruiting
- Registry status
- 100
- Enrollment target
- 2
- Study locations
NCT04291755: Recruiting study of Carcinoma, Non-Small Cell Lung and Carcinoma, Colorectal, sponsored by Persephone Biosciences.
NCT04291755 is a study of Carcinoma, Non-Small Cell Lung and Carcinoma, Colorectal that is actively recruiting participants, run by Persephone Biosciences. The registered enrollment target is 100 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04291755, a study of Carcinoma, Non-Small Cell Lung and Carcinoma, Colorectal, is actively recruiting participants, sponsored by Persephone Biosciences.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Response of the tumor to treatment, as evaluated by the iRECIST criteria
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 |
What NCT04291755 shows while recruiting
NCT04291755 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (69% lower).
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.
NCT04291755 reports a single indexed study location in California, Florida.
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.
What interventions are being tested in trial NCT04291755?
The interventions under investigation include: Pembrolizumab Injection (DRUG).
Who is sponsoring clinical trial NCT04291755?
This trial is sponsored by Persephone Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04291755's enrollment target sits among peer trials
100 72nd of 130 higher than 58 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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