Development and Analysis of a Stool Bank for Cancer Patients

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

Development and Analysis of a Stool Bank for Cancer Patients

Condition
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment

-

Contacts and Locations

Fountain Valley

Compassionate Care Research Group, Inc., Fountain Valley, California, United States, 92708

Winter Haven

Bond and Steele Clinic, P.A., Winter Haven, Florida, United States, 33881

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Persephone Biosciences,

Study Record Dates

2028-12-31