RecruitingNot applicableNCT04291755

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 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.

Checked against the public recordLast updated Apr 5, 2024 · Source: ClinicalTrials.gov

StatusRecruiting
PhaseNot applicable
U.S. locations2
SponsorPersephone Biosciences
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Persephone Biosciences
Interventions being studied
Drug: Pembrolizumab Injection
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

Inclusion Criteria: * Men or women who are ≥ 18 years old who are undergoing any type of cancer immunotherapy * Subjects who are able to provide written informed consent Exclusion Criteria: * Subjects with HIV, Hepatitis B, or Hepatitis C * Subjects without the mental capacity to complete either a written or online questionnaire, alone or with assistance, or make sound decisions * Women who are pregnant or who plan on becoming pregnant * Women who are nursing

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Compassionate Care Research Group, Inc.Fountain Valley, California
  • Bond and Steele Clinic, P.A.Winter Haven, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 5, 2024. Always confirm current availability with the study team.

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