Colorectal Cancer, Non-small Cell Lung Cancer, Pancreas Cancer, Triple Negative Breast Cancer
Conditions
Keywords
microbiome, immunotherapy, checkpoint inhibitor, cancer, colonoscopy
Brief summary
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.
Interventions
DRUGImmunotherapy
Checkpoint inhibitor
DRUGChemotherapy
Any form of chemotherapy
PROCEDURECRC surgical resection
Surgical resection to remove colorectal cancer
PROCEDUREColonoscopy
Standard-of-care colonoscopy for CRC screening
Sponsors
Persephone Biosciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine whether the microbiome composition can predict progression-free survival | 6-12 months | Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome, and whether there is any correlation with response to treatment |
| Determine whether the microbiome composition can predict risk for colorectal cancer | 2-8 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify correlations between microbiome composition and immune markers | 6-12 months | CyTOF and cytokine analysis will be performed on the blood samples to characterize the patient's immune phenotype |
| Determine whether the microbiome composition can predict overall survival | 6-24 months | Survival and tumor progression will be monitored for an extended time beyond sample collection |
| Build a library of samples and data for future research | 6-24 months | Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata. |
Countries
United States
Contacts
Primary ContactStephanie Culler, PhD
Backup ContactStephen Van Dien, PhD
Outcome results
None listed