Development and Analysis of a Stool Bank for Cancer Patients
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|ClinicalTrials.gov Identifier: NCT04291755|
Recruitment Status : Active, not recruiting
First Posted : March 2, 2020
Last Update Posted : March 10, 2021
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.
|Condition or disease||Intervention/treatment|
|Carcinoma, Non-Small-Cell Lung Carcinoma, Colorectal||Drug: Pembrolizumab Injection|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||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|
|Actual Study Start Date :||June 28, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
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.
Drug: Pembrolizumab Injection
Any checkpoint inhibitor is acceptable
Other Name: nivolumab, ipilimumab, atlizumab
- Checkpoint inhibitor response [ Time Frame: 6-12 months ]Response of the tumor to treatment, as evaluated by the iRECIST criteria
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291755
|United States, California|
|Compassionate Care Research Group, Inc.|
|Fountain Valley, California, United States, 92708|
|United States, Florida|
|Bond and Steele Clinic, P.A.|
|Winter Haven, Florida, United States, 33881|