NCT04638751Suspended
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
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Reason given: Currently no funding to continue study.
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 16 Nov 2020
- Start date
- 1 Jul 2022
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Persephone Biosciences
- NCT number
- NCT04638751
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV2
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baton Rouge General Medical Center | Baton Rouge | United States | Unknown status |
| Kroger Health, The Little Clinic | Cincinnati | United States | Unknown status |
| Southwest Family Medicine Associates | Dallas | United States | Unknown status |
| Biopharma Informatic | Houston | United States | Unknown status |
| L&A Morales Healthcare, Inc | Miami | United States | Unknown status |
| University Medical Center New Orleans | New Orleans | United States | Unknown status |
| Mid Hudson Medical Research | New Windsor | United States | Unknown status |
| Knowledge Research Center | Orange | United States | Unknown status |
| SDG Clinical Research, Inc. | San Diego | United States | Unknown status |
| Persephone Biosciences, Inc. | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.