ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Triple Negative Breast Cancer; Non-small Cell Lung Cancer; Pancreas Cancer
• Intervention / Treatment: Drug: Immunotherapy; Drug: Chemotherapy; Procedure: CRC surgical resection; Procedure: Colonoscopy

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Stephen Van Dien, PhD; Phone Number: 858-682-4777; Email: support@persephonebiome.com
• Study Contact Backup: Name: Stephanie Culler, PhD; Phone Number: 858-682-4777; Email: support@persephonebiome.com

Study Locations

• United States
  • California
    • Orange, California, United States, 92866
      • Recruiting
      • Knowledge Research Center
      • Contact: Vicki Tan; Phone Number: 657-247-0087; Email: v.tan@knowledgeresearchcenter.com
      • Principal Investigator: Alaa Abousaif, MD
    • San Diego, California, United States, 92121
      • Recruiting
      • Persephone Biosciences, Inc.
      • Contact: Stephen Van Dien, PhD; Phone Number: 858-682-4777; Email: support@persephonebiome.com
      • Contact: Stephanie Culler, PhD; Phone Number: 858-682-4777; Email: support@persephonebiome.com
    • San Diego, California, United States, 92103
      • Recruiting
      • SDG Clinical Research, Inc
      • Principal Investigator: Andrew Cummins, MD
      • Contact: Nancy Giovanetty; Phone Number: 619-291-6064; Email: nancy@sdgastro.com
  • Florida
    • Miami, Florida, United States, 33142
      • Recruiting
      • L&A Morales Healthcare, Inc
      • Contact: Anya Gutierrez; Phone Number: 786-360-1458; Email: agutierrez@moraleshealthcare.com
      • Principal Investigator: Enrique Villa, MD
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Baton Rouge General Medical Center
      • Contact: Jamie Mooney; Phone Number: 225-763-4828; Email: jam422@brgeneral.org
      • Principal Investigator: Scott Daugherty, MD
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • University Medical Center New Orleans
      • Contact: Tae'lar Henry; Phone Number: 504-702-2440; Email: taelar.henry@lcmchealth.org
      • Principal Investigator: Virendra Joshi, MD
  • New York
    • New Windsor, New York, United States, 12553
      • Recruiting
      • Mid-Hudson Medical Research
      • Contact: Cassandra Newman; Phone Number: 845-674-9398; Email: cnewman@mhmresearch.com
      • Principal Investigator: Sashi K Makam, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45202
      • Recruiting
      • Kroger Health, The Little Clinic
      • Contact: Chad Wolf; Phone Number: 513-748-1825; Email: Chad.wolf@thelittleclinic.com
      • Principal Investigator: Marc Watkins, MD
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • Southwest Family Medicine Associates
      • Principal Investigator: Chrisette Dharma, MD
      • Contact: Neven Gerges; Phone Number: 469-893-1242; Email: neven@southwestfamilymed.com
    • Houston, Texas, United States, 77089
      • Terminated
      • Biopharma Informatic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether the microbiome composition can predict progression-free survival	Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome, and whether there is any correlation with response to treatment	6-12 months
Determine whether the microbiome composition can predict risk for colorectal cancer	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.	2-8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify correlations between microbiome composition and immune markers	CyTOF and cytokine analysis will be performed on the blood samples to characterize the patient's immune phenotype	6-12 months
Determine whether the microbiome composition can predict overall survival	Survival and tumor progression will be monitored for an extended time beyond sample collection	6-24 months
Build a library of samples and data for future research	Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata.	6-24 months

Collaborators and Investigators

• Sponsor: Persephone Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: immunotherapy; cancer; colonoscopy; microbiome; checkpoint inhibitor
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Breast Diseases; Pancreatic Diseases; Breast Neoplasms; Pancreatic Neoplasms; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: PB-2020-01

Drug and device information, study documents

• 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