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 Type
OBSERVATIONAL
Enrollment
5,000
Checkpoint inhibitor
Any form of chemotherapy
Surgical resection to remove colorectal cancer
Standard-of-care colonoscopy for CRC screening
Knowledge Research Center
Orange, California, United States
RECRUITINGSDG Clinical Research, Inc
San Diego, California, United States
RECRUITINGPersephone Biosciences, Inc.
San Diego, California, United States
RECRUITINGL&A Morales Healthcare, Inc
Miami, Florida, United States
RECRUITINGBaton Rouge General Medical Center
Baton Rouge, Louisiana, United States
RECRUITINGUniversity Medical Center New Orleans
New Orleans, Louisiana, United States
RECRUITINGMid-Hudson Medical Research
New Windsor, New York, United States
RECRUITINGKroger Health, The Little Clinic
Cincinnati, Ohio, United States
RECRUITINGSouthwest Family Medicine Associates
Dallas, Texas, United States
RECRUITINGBiopharma Informatic
Houston, Texas, United States
TERMINATEDDetermine whether the microbiome composition can predict progression-free survival
Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome, and whether there is any correlation with response to treatment
Time frame: 6-12 months
Determine whether the microbiome composition can predict risk for colorectal cancer
Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome. High and low risk subjects will be followed for 8 years to determine if any get CRC.
Time frame: 2-8 years
Identify correlations between microbiome composition and immune markers
CyTOF and cytokine analysis will be performed on the blood samples to characterize the patient's immune phenotype
Time frame: 6-12 months
Determine whether the microbiome composition can predict overall survival
Survival and tumor progression will be monitored for an extended time beyond sample collection
Time frame: 6-24 months
Build a library of samples and data for future research
Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata.
Time frame: 6-24 months
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