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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04638751
Other study ID # PB-2020-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Persephone Biosciences
Contact Stephanie Culler, PhD
Phone 858-682-4777
Email support@persephonebiome.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Baton Rouge General Medical Center Baton Rouge Louisiana
United States Kroger Health, The Little Clinic Cincinnati Ohio
United States Southwest Family Medicine Associates Dallas Texas
United States Biopharma Informatic Houston Texas
United States L&A Morales Healthcare, Inc Miami Florida
United States University Medical Center New Orleans New Orleans Louisiana
United States Mid-Hudson Medical Research New Windsor New York
United States Knowledge Research Center Orange California
United States Persephone Biosciences, Inc. San Diego California
United States SDG Clinical Research, Inc San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Persephone Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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