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ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

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ClinicalTrials.gov Identifier: NCT04638751
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Persephone Biosciences

Study Description
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Brief Summary:

ARGONAUT is a longitudinal, prospective, observational study that will enroll up to 5,000 advanced-stage cancer patients of diverse racial backgrounds to collect data used to develop precision microbiome medicines and for the identification of clinically actionable cancer-specific biomarkers to guide therapeutic decisions. Four types of solid tumor cancers will be profiled including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) and pancreatic cancer. Healthy control subjects without a cancer diagnosis will also be studied, comprised of individuals at high risk for CRC and healthy individuals at low risk for CRC. Risk assessment will be based on family history or past neoplastic findings during CRC screening. Data collected from this study will be used to develop the most effective new therapies, via microbiome optimization, all to the benefit of patients and the physicians treating them. Stool and blood samples will be collected longitudinally and analyzed to determine the impact of gut microbiome composition and function on the immune system and efficacy of the treatment.

Currently enrolling the CRC, high risk, and low risk cohorts.

Subjects who meet the entry criteria will provide up to 5 samples each of blood and stool over a 2-year period. Approximately 10%-20% of the subjects will provide colon tissue samples, either from research biopsies during Standard of Care (SOC) screening colonoscopy or retained surgical tissue from colectomy. Electronic health records will be obtained at various times for up to 8 years, to collect tumor imaging results and any other updated medical data, with no additional samples collected. In select cases, stool and blood samples will be collected beyond 2 years.


Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Colorectal Cancer Triple Negative Breast Cancer Pancreas Cancer Drug: Immunotherapy Drug: Chemotherapy Procedure: CRC surgical resection Procedure: Colonoscopy

Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ARGONAUT: Development and Analysis of a Blood and Stool Sample Bank for Cancer Patients, Enabling the Systematic Study of the Effect of Gut Microbiomes on Response to Treatment
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Groups and Cohorts
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Group/Cohort Intervention/treatment
NSCLC
Stage 3 or stage 4 non-small cell lung cancer patients, being administered checkpoint inhibitor therapy for the first time. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
 Drug: Immunotherapy
Checkpoint inhibitor
Triple-negative breast cancer
Stage 3 or stage 4 metastatic triple-negative breast cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
 Drug: Chemotherapy
Any form of chemotherapy
Colorectal cancer
Stage 3 or stage 4 colorectal cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
 Drug: Immunotherapy
Checkpoint inhibitor

Drug: Chemotherapy
Any form of chemotherapy

Procedure: CRC surgical resection
Surgical resection to remove colorectal cancer
Pancreatic cancer
Stage 3 or stage 4 pancreatic cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
 Drug: Immunotherapy
Checkpoint inhibitor

Drug: Chemotherapy
Any form of chemotherapy
High risk for colorectal cancer
Subjects undergoing a standard-of-care colonoscopy for colorectal cancer (CRC) screening considered at high risk for CRC due to either 1) one or more first degree relatives with a history of CRC, or 2) a personal history of colorectal cancer, advanced adenoma as defined by USMSTF guidelines on colorectal cancer, or 3 or more non-advanced adenomas in a single screening or surveillance encounter (synchronous).
 Procedure: Colonoscopy
Standard-of-care colonoscopy for CRC screening
Low risk for colorectal cancer
Subjects undergoing a standard-of-care colonoscopy for colorectal cancer (CRC) screening, who are not considered high risk for CRC based on family history or prior colonoscopy findings.
 Procedure: Colonoscopy
Standard-of-care colonoscopy for CRC screening


Outcome Measures
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Primary Outcome Measures :
  1. Determine whether the microbiome composition can predict progression-free survival [ Time Frame: 6-12 months ]
    Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome, and whether there is any correlation with response to treatment

  2. Determine whether the microbiome composition can predict risk for colorectal cancer [ Time Frame: 2-8 years ]
    Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome. High and low risk subjects will be followed for 8 years to determine if any get CRC.


Secondary Outcome Measures :
  1. Identify correlations between microbiome composition and immune markers [ Time Frame: 6-12 months ]
    CyTOF and cytokine analysis will be performed on the blood samples to characterize the patient's immune phenotype

  2. Determine whether the microbiome composition can predict overall survival [ Time Frame: 6-24 months ]
    Survival and tumor progression will be monitored for an extended time beyond sample collection

  3. Build a library of samples and data for future research [ Time Frame: 6-24 months ]
    Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata.


Biospecimen Retention:   Samples With DNA
Stool and blood samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
It is anticipated that up to 5000 subjects will be enrolled in this study. It is preferred that enrollment is balanced by sex; however, it is not required. All efforts will be made to provide racial/ethnic balance, with a goal of 20% African American and 10% each of patients with Asian or Hispanic descent.
Criteria

Inclusion Criteria:

  • Men or women who are ≥ 18 years old with stage III or stage IV non-small cell lung cancer (NSCLC), colorectal cancer, triple-negative breast cancer, or pancreatic cancer treated by a particular cancer treatment for the first time, OR healthy subjects undergoing a standard of care colonoscopy
  • Subjects able to provide written informed consent

Exclusion Criteria:

  • Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV2
  • 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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04638751


Contacts
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Contact: Stephanie Culler, PhD 858-682-4777 support@persephonebiome.com
Contact: Stephen Van Dien, PhD 858-682-4777 support@persephonebiome.com

Locations
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United States, California
Knowledge Research Center Recruiting
Orange, California, United States, 92866
Contact: Vicki Tan    657-247-0087    v.tan@knowledgeresearchcenter.com   
Principal Investigator: Alaa Abousaif, MD         
SDG Clinical Research, Inc Not yet recruiting
San Diego, California, United States, 92103
Contact: Nancy Giovanetty    619-291-6064    nancy@sdgastro.com   
Principal Investigator: Andrew Cummins, MD         
Persephone Biosciences, Inc. Recruiting
San Diego, California, United States, 92121
Contact: Stephanie Culler, PhD    858-682-4777    support@persephonebiome.com   
Contact: Stephen Van Dien, PhD    858-682-4777    support@persephonebiome.com   
United States, Florida
L&A Morales Healthcare, Inc Recruiting
Miami, Florida, United States, 33142
Contact: Anya Gutierrez    786-360-1458    agutierrez@moraleshealthcare.com   
Principal Investigator: Enrique Villa, MD         
United States, Louisiana
Baton Rouge General Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Jamie Mooney    225-763-4828    jam422@brgeneral.org   
Principal Investigator: Scott Daugherty, MD         
United States, New York
Mid-Hudson Medical Research Recruiting
New Windsor, New York, United States, 12553
Contact: Cassandra Newman    845-674-9398    cnewman@mhmresearch.com   
Principal Investigator: Sashi K Makam, MD         
United States, Ohio
Kroger Health, The Little Clinic Not yet recruiting
Cincinnati, Ohio, United States, 45202
Contact: Chad Wolf    513-748-1825    Chad.wolf@thelittleclinic.com   
Principal Investigator: Marc Watkins, MD         
United States, Texas
Southwest Family Medicine Associates Recruiting
Dallas, Texas, United States, 75235
Contact: Neven Gerges    469-893-1242    neven@southwestfamilymed.com   
Principal Investigator: Chrisette Dharma, MD         
Biopharma Informatic Recruiting
Houston, Texas, United States, 77089
Contact: Humaira Adnan    315-663-6617    Humaira@biopharmainfo.net   
Principal Investigator: Irfan Jawed, MD         
Sponsors and Collaborators
Persephone Biosciences
More Information
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Responsible Party: Persephone Biosciences
ClinicalTrials.gov Identifier: NCT04638751    
Other Study ID Numbers: PB-2020-01
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023

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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:
microbiome
immunotherapy
checkpoint inhibitor
cancer
colonoscopy
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Breast Neoplasms
Breast Diseases
 Skin Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Immunomodulating Agents
Immunologic Factors
Physiological Effects of Drugs