ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

Description

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.

Conditions

Non-small Cell Lung Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Pancreas Cancer

Study Overview

Study Details

Study overview

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.

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

ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

Condition
Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Orange

Knowledge Research Center, Orange, California, United States, 92866

San Diego

SDG Clinical Research, Inc, San Diego, California, United States, 92103

San Diego

Persephone Biosciences, Inc., San Diego, California, United States, 92121

Miami

L&A Morales Healthcare, Inc, Miami, Florida, United States, 33142

Baton Rouge

Baton Rouge General Medical Center, Baton Rouge, Louisiana, United States, 70809

New Orleans

University Medical Center New Orleans, New Orleans, Louisiana, United States, 70112

New Windsor

Mid-Hudson Medical Research, New Windsor, New York, United States, 12553

Cincinnati

Kroger Health, The Little Clinic, Cincinnati, Ohio, United States, 45202

Dallas

Southwest Family Medicine Associates, Dallas, Texas, United States, 75235

Houston

Biopharma Informatic, Houston, Texas, United States, 77089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Persephone Biosciences,

Study Record Dates

2025-12-31