RECRUITING

Development and Analysis of a Stool Bank for Cancer Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2019-06-28
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04291755

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men or women who are ≥ 18 years old who are undergoing any type of cancer immunotherapy
  2. * Subjects who are able to provide written informed consent
  1. * Subjects with HIV, Hepatitis B, or Hepatitis C
  2. * Subjects without the mental capacity to complete either a written or online questionnaire, alone or with assistance, or make sound decisions
  3. * Women who are pregnant or who plan on becoming pregnant
  4. * Women who are nursing

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
858-682-4777
support@persephonebiome.com

Study Locations (Sites)

Compassionate Care Research Group, Inc.
Fountain Valley, California, 92708
United States
Bond and Steele Clinic, P.A.
Winter Haven, Florida, 33881
United States

Collaborators and Investigators

Sponsor: Persephone Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-28
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2019-06-28
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Non-small cell lung cancer
  • immunotherapy
  • checkpoint inhibitor
  • pembrolizumab
  • nivolumab
  • ipilimumab
  • microbiome

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Colorectal