ARGONAUT: Stool and Blood Sample Bank for Cancer Patients
Public ClinicalTrials.gov record NCT04638751. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04638751
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 5,000 participants
Conditions and interventions
Conditions
Interventions
- Immunotherapy Drug
- Chemotherapy Drug
- CRC surgical resection Procedure
- Colonoscopy Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2022
- Primary completion
- Dec 30, 2024
- Completion
- Dec 30, 2025
- Last update posted
- Apr 4, 2024
2022 – 2025
United States locations
- U.S. sites
- 10
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Knowledge Research Center | Orange | California | 92866 | Recruiting |
| SDG Clinical Research, Inc | San Diego | California | 92103 | Recruiting |
| Persephone Biosciences, Inc. | San Diego | California | 92121 | Recruiting |
| L&A Morales Healthcare, Inc | Miami | Florida | 33142 | Recruiting |
| Baton Rouge General Medical Center | Baton Rouge | Louisiana | 70809 | Recruiting |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | Recruiting |
| Mid-Hudson Medical Research | New Windsor | New York | 12553 | Recruiting |
| Kroger Health, The Little Clinic | Cincinnati | Ohio | 45202 | Recruiting |
| Southwest Family Medicine Associates | Dallas | Texas | 75235 | Recruiting |
| Biopharma Informatic | Houston | Texas | 77089 | Terminated |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04638751, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 4, 2024 · Synced Sep 4, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04638751 live on ClinicalTrials.gov.