ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

Persephone Biosciences

Status: Enrolling

Conditions: Non-small Cell Lung Cancer; Pancreas Cancer; Triple Negative Breast Cancer; Colorectal Cancer

Treatments: Drug: Chemotherapy; Drug: Immunotherapy; Procedure: CRC surgical resection; Procedure: Colonoscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT04638751

PB-2020-01

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

5,000 participants in 6 patient groups

NSCLC

Description:

Stage 3 or stage 4 non-small cell lung cancer patients, being administered checkpoint inhibitor therapy for the first time. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.

Treatment:

Drug: Immunotherapy

Triple-negative breast cancer

Description:

Stage 3 or stage 4 metastatic triple-negative breast cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.

Treatment:

Drug: Chemotherapy

Colorectal cancer

Description:

Stage 3 or stage 4 colorectal cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.

Treatment:

Drug: Chemotherapy

Procedure: CRC surgical resection

Drug: Immunotherapy

Pancreatic cancer

Description:

Stage 3 or stage 4 pancreatic cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.

Treatment:

Drug: Chemotherapy

Drug: Immunotherapy

High risk for colorectal cancer

Description:

Subjects undergoing a standard-of-care colonoscopy for colorectal cancer (CRC) screening considered at high risk for CRC due to either 1) one or more first degree relatives with a history of CRC, or 2) a personal history of colorectal cancer, advanced adenoma as defined by USMSTF guidelines on colorectal cancer, or 3 or more non-advanced adenomas in a single screening or surveillance encounter (synchronous).

Treatment:

Procedure: Colonoscopy

Low risk for colorectal cancer

Description:

Subjects undergoing a standard-of-care colonoscopy for colorectal cancer (CRC) screening, who are not considered high risk for CRC based on family history or prior colonoscopy findings.

Treatment:

Procedure: Colonoscopy