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Development and Analysis of a Stool Bank for Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04291755
Recruitment Status : Active, not recruiting
First Posted : March 2, 2020
Last Update Posted : March 10, 2021
Pharm-Olam International
Information provided by (Responsible Party):
Persephone Biosciences

Brief Summary:

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.

Condition or disease Intervention/treatment
Carcinoma, Non-Small-Cell Lung Carcinoma, Colorectal Drug: Pembrolizumab Injection

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Checkpoint inhibitor therapy
Patients will be administered a checkpoint inhibitor therapy, including but not limited to pembrolizumab, nivolumab, ipilimumab, and atlizumab, at the standard dosing regimen prescribed by their physician. Stool, blood, and urine samples will be collected from patients prior to start of treatment, and at 4 more timepoints over the next 12 months.
Drug: Pembrolizumab Injection
Any checkpoint inhibitor is acceptable
Other Name: nivolumab, ipilimumab, atlizumab

Primary Outcome Measures :
  1. Checkpoint inhibitor response [ Time Frame: 6-12 months ]
    Response of the tumor to treatment, as evaluated by the iRECIST criteria

Biospecimen Retention:   Samples With DNA
Stool, blood, and urine specimens from each patient

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any person meeting the above 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04291755

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United States, California
Compassionate Care Research Group, Inc.
Fountain Valley, California, United States, 92708
United States, Florida
Bond and Steele Clinic, P.A.
Winter Haven, Florida, United States, 33881
Sponsors and Collaborators
Persephone Biosciences
Pharm-Olam International
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Responsible Party: Persephone Biosciences Identifier: NCT04291755    
Other Study ID Numbers: PB-002
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Persephone Biosciences:
Non-small cell lung cancer
checkpoint inhibitor
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action