Collecting stool samples from cancer patients to study gut microbiota
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
This study is trying to see how the bacteria in the gut of cancer patients might affect how well their immunotherapy treatments work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Persephone Biosciences Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Fountain Valley, California and 1 other locations) |
| Trial ID | NCT04291755 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand how gut microbiota affects the efficacy of cancer therapies, particularly checkpoint inhibitors. By collecting blood, urine, and stool samples from 100 cancer patients undergoing immunotherapy, researchers will analyze these samples to identify microbial species and metabolic processes linked to treatment success. The study utilizes metabolic models and machine learning to explore the relationship between gut microbes and cancer treatment outcomes, ultimately aiming to develop microbial immunotherapies. This non-interventional study is conducted at two sites in the United States.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 and older who are currently undergoing any type of cancer immunotherapy.
Not a fit: Patients with HIV, Hepatitis B, or Hepatitis C, as well as pregnant or nursing women, may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved cancer treatment outcomes through the development of microbial co-therapies.
How similar studies have performed: Other studies have shown promising results in understanding the role of gut microbiota in cancer treatment, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Fountain Valley, California and 1 other locations
- Compassionate Care Research Group, Inc. — Fountain Valley, California, United States (Recruiting)
- Bond and Steele Clinic, P.A. — Winter Haven, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Study Coordinator
- Email: support@persephonebiome.com
- Phone: 858-682-4777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.