Development and Analysis of a Stool Bank for Cancer Patients

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Persephone Biosciences
Study ID
NCT04291755
Status
Recruiting
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Conditions

  • Carcinoma, Colorectal
  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab Injection — DRUG
    Any checkpoint inhibitor is acceptable

Study Details

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.

Key Dates

Start date
Jun 28, 2019
Status verified
Apr 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Checkpoint inhibitor response [ Time Frame: 6-12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Compassionate Care Research Group, Inc.Fountain ValleyCalifornia92708
Esther Jayachandran
[email protected]
714-338-2154
Derrick Su, MD (PRINCIPAL_INVESTIGATOR)
Bond and Steele Clinic, P.A.Winter HavenFlorida33881
Nikki Denmark
[email protected]
863-293-1191
Osama Hlalah, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fountain Valley, CA

By research site
Compassionate Care Research Group, Inc.· Fountain Valley, CABond and Steele Clinic, P.A.· Winter Haven, FL

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