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NCT04291755Enrolling by invitation

Development and Analysis of a Stool Bank for Cancer Patients

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

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
100 (estimated)
First submitted
27 Feb 2020
Start date
28 Jun 2019
Primary completion date
31 Dec 2028
Lead sponsor
Persephone Biosciences
NCT number
NCT04291755

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 28 Jun 2019 to the primary completion date, 31 Dec 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Subjects with HIV, Hepatitis B, or Hepatitis C

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Compassionate Care Research Group, Inc.
Coordinator of this site? Confirm its status
Fountain ValleyUnited StatesUnknown status
Bond and Steele Clinic, P.A.
Coordinator of this site? Confirm its status
Winter HavenUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.