Collecting stool and blood samples from 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
This study is collecting stool and blood samples from advanced-stage cancer patients to see if it can help create better treatments and identify specific markers for different types of cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Persephone Biosciences Industry-sponsored |
| Locations | 10 sites (Orange, California and 9 other locations) |
| Trial ID | NCT04638751 on ClinicalTrials.gov |
What this trial studies
ARGONAUT is a longitudinal observational study aimed at enrolling up to 5,000 advanced-stage cancer patients from diverse racial backgrounds. The study focuses on collecting stool and blood samples to develop precision microbiome medicines and identify cancer-specific biomarkers that can guide treatment decisions. It will profile four types of solid tumors: non-small cell lung cancer, triple negative breast cancer, colorectal cancer, and pancreatic cancer, while also including healthy control subjects. The data gathered will help optimize microbiome therapies for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 and older with stage III or IV non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, or pancreatic cancer, as well as healthy individuals undergoing a standard colonoscopy.
Not a fit: Patients with known HIV, hepatitis infections, or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of more effective therapies tailored to individual cancer patients based on their microbiome.
How similar studies have performed: Other studies have shown promise in utilizing microbiome data for cancer treatment, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Orange, California and 9 other locations
- Knowledge Research Center — Orange, California, United States (Recruiting)
- SDG Clinical Research, Inc — San Diego, California, United States (Recruiting)
- Persephone Biosciences, Inc. — San Diego, California, United States (Recruiting)
- L&A Morales Healthcare, Inc — Miami, Florida, United States (Recruiting)
- Baton Rouge General Medical Center — Baton Rouge, Louisiana, United States (Recruiting)
- University Medical Center New Orleans — New Orleans, Louisiana, United States (Recruiting)
- Mid-Hudson Medical Research — New Windsor, New York, United States (Recruiting)
- Kroger Health, The Little Clinic — Cincinnati, Ohio, United States (Recruiting)
- Southwest Family Medicine Associates — Dallas, Texas, United States (Recruiting)
- Biopharma Informatic — Houston, Texas, United States (Terminated)
Study contacts
- Study coordinator: Stephanie Culler, PhD
- Email: support@persephonebiome.com
- Phone: 858-682-4777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.