ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638751
• Other study ID #: PB-2020-01
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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