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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 : April 5, 2024
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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