Development and Analysis of a Stool Bank for Cancer Patients
Recruiting · NCT04291755 · Observational (researchers observe without assigning treatment) · Lead sponsor: Persephone Biosciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 2 US states.
- Compassionate Care Research Group, Inc. - Fountain Valley, California, United States
- Bond and Steele Clinic, P.A. - Winter Haven, Florida, United States