ARGONAUT: Stool and Blood Sample Bank for Cancer Patients
Status unconfirmed
Conditions studied: Non-small Cell Lung Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Pancreas Cancer
In brief
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.
Key facts
- Study ID
- NCT04638751
- Run by
- Persephone Biosciences
- People needed
- 5000
- Starts
- 2022-07-01
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2024-04-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Knowledge Research Center — Orange, California, United States (enrolling)
- SDG Clinical Research, Inc — San Diego, California, United States (enrolling)
- Persephone Biosciences, Inc. — San Diego, California, United States (enrolling)
- L&A Morales Healthcare, Inc — Miami, Florida, United States (enrolling)
- Baton Rouge General Medical Center — Baton Rouge, Louisiana, United States (enrolling)
- University Medical Center New Orleans — New Orleans, Louisiana, United States (enrolling)
- Mid-Hudson Medical Research — New Windsor, New York, United States (enrolling)
- Kroger Health, The Little Clinic — Cincinnati, Ohio, United States (enrolling)
- Southwest Family Medicine Associates — Dallas, Texas, United States (enrolling)
- Biopharma Informatic — Houston, Texas, United States
Full record on ClinicalTrials.gov
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