Development and Analysis of a Stool Bank for Cancer Patients

StatusEnrolling by Invitation
PhaseNot specified
Started

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Record History

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  1. Minor Trial status changed: Recruiting → Enrolling by Invitation
    • Eligibility criteria expanded, about 6 words
    • Site details revised at 2 of 2 sites
  2. Notable Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Dec 31, 2022 to Dec 31, 2028
    • Site details revised at 2 of 2 sites
    v4
  3. Notable Primary and study completion dates pushed to Dec 31, 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04291755
Lead Sponsor Persephone Biosciences
Collaborators: Pharm-Olam International
Conditions
(from sponsor)
Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal
Related terms Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov