NCT04638751

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Persephone Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2020-11-20
• Last updated: 2024-04-05

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study