ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

• ClinicalTrials.gov Identifier: NCT04638751
• Recruitment Status: Recruiting
• First Posted: November 20, 2020
• Last Update Posted: April 5, 2024
• Sponsor: Persephone Biosciences
• Information provided by (Responsible Party): Persephone Biosciences

Tracking Information

• First Submitted Date: November 16, 2020
• First Posted Date: November 20, 2020
• Last Update Posted Date: April 5, 2024
• Actual Study Start Date: July 1, 2022
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 23, 2023)

• 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
• 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.

Original Primary Outcome Measures (submitted: November 16, 2020)

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

Current Secondary Outcome Measures (submitted: November 16, 2020)

• 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
• 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
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ARGONAUT: Stool and Blood Sample Bank for Cancer Patients
• 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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Stool and blood samples

• 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.

Condition

• Non-small Cell Lung Cancer
• Colorectal Cancer
• Triple Negative Breast Cancer
• Pancreas Cancer

Intervention

• Drug: Immunotherapy
  Checkpoint inhibitor
• Drug: Chemotherapy
  Any form of chemotherapy
• Procedure: CRC surgical resection
  Surgical resection to remove colorectal cancer
• Procedure: Colonoscopy
  Standard-of-care colonoscopy for CRC screening

Study Groups/Cohorts

• 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.
  Intervention: Drug: Immunotherapy
• 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.
  Intervention: Drug: 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.
  Interventions:

  • Drug: Immunotherapy
  • Drug: Chemotherapy
  • Procedure: CRC surgical resection
• 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.
  Interventions:

  • Drug: Immunotherapy
  • Drug: 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).
  Intervention: Procedure: Colonoscopy
• 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.
  Intervention: Procedure: Colonoscopy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 23, 2023): 5000
• Original Estimated Enrollment (submitted: November 16, 2020): 4000
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Stephanie Culler, PhD; 858-682-4777; support@persephonebiome.com

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04638751
• Other Study ID Numbers: PB-2020-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Persephone Biosciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Persephone Biosciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Persephone Biosciences
• Verification Date: April 2024