Development and Analysis of a Sample Bank (Blood, Urine, and Stool) for Cancer Patients, Enabling the Systematic Study of the Effect of Blood, Urinary Tract, and Gut Microbiomes on Response to Treatment

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Compassionate Care Research Group, Inc.
RECRUITING
Fountain Valley
Florida
Bond and Steele Clinic, P.A.
RECRUITING
Winter Haven
Contact Information
Primary
Study Coordinator
support@persephonebiome.com
858-682-4777
Time Frame
Start Date: 2019-06-28
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
Checkpoint inhibitor therapy
Patients will be administered a checkpoint inhibitor therapy, including but not limited to pembrolizumab, nivolumab, ipilimumab, and atlizumab, at the standard dosing regimen prescribed by their physician. Stool, blood, and urine samples will be collected from patients prior to start of treatment, and at 4 more timepoints over the next 12 months.
Sponsors
Collaborators: Pharm-Olam International
Leads: Persephone Biosciences

This content was sourced from clinicaltrials.gov