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
Persephone Biosciences
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.
Description
A growing body of evidence indicates that the composition of the gut microbiome can influence the efficacy of cancer drugs. For example, it has recently been demonstrated that the presence of certain microbes in the gut is correlated with better responsiveness to the new immunotherapy drugs known as checkpoint inhibitors. Providing these particular microbes as a co-therapy may be a way to improve the overall success rate of these drugs. However, very little is currently known about the mechanisms involved in these observed positive effects. In order to systematically identify how the presence…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugPembrolizumab Injection
Any checkpoint inhibitor is acceptable
Locations (2)
- Compassionate Care Research Group, Inc.Fountain Valley, California
- Bond and Steele Clinic, P.A.Winter Haven, Florida