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ARGONAUT: Stool and Blood Sample Bank for Cancer Patients
NCT04638751 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- PROCEDURE Colonoscopy
- DRUG Chemotherapy
- DRUG Immunotherapy
- PROCEDURE CRC surgical resection
Study Locations (10)
California
- Knowledge Research Center — Orange
- SDG Clinical Research, Inc — San Diego
- Persephone Biosciences, Inc. — San Diego
Louisiana
- Baton Rouge General Medical Center — Baton Rouge
- University Medical Center New Orleans — New Orleans
Texas
- Southwest Family Medicine Associates — Dallas
- Biopharma Informatic — Houston
Florida
- L&A Morales Healthcare, Inc — Miami
New York
- Mid-Hudson Medical Research — New Windsor
Ohio
- Kroger Health, The Little Clinic — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2025-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04638751
The ClinicalTrials.gov registry entry for NCT04638751 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Persephone Biosciences, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions — of which Colonoscopy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04638751 reports 10 study locations spanning 6 distinct geographic areas — top geographies include California, Louisiana, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04638751 about?
NCT04638751 is a clinical study titled "ARGONAUT: Stool and Blood Sample Bank for Cancer Patients". 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 guid...
What is the current status of trial NCT04638751?
This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 2022-07-01. Estimated completion is 2025-12-31.
What conditions does trial NCT04638751 study?
This clinical trial studies the following conditions: Colorectal Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Pancreas Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04638751?
The interventions under investigation include: Colonoscopy (PROCEDURE), Chemotherapy (DRUG), Immunotherapy (DRUG), CRC surgical resection (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04638751?
This trial is sponsored by Persephone Biosciences, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04638751 being conducted?
This trial has 10 study locations across California, Florida, Louisiana, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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