ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

NCT04638751 | Recruiting FDA Drug

• 1 other identifier: PB-2020-01
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Keywords

microbiome; immunotherapy; checkpoint inhibitor; cancer; colonoscopy

Outcome Measures

Primary Outcomes (2)

• Determine 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

  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.

  2-8 years

Secondary Outcomes (3)

• Identify correlations between microbiome composition and immune markers

  6-12 months

• Determine whether the microbiome composition can predict overall survival

  6-24 months

• Build a library of samples and data for future research

  6-24 months

Study Arms (6)

NSCLC

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.

Drug: Immunotherapy

Triple-negative breast cancer

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.

Drug: Chemotherapy

Colorectal cancer

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.

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

Pancreatic cancer

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.

Drug: Immunotherapy; Drug: Chemotherapy

High risk for colorectal cancer

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).

Procedure: Colonoscopy

Low risk for colorectal cancer

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.

Procedure: Colonoscopy

Interventions

Immunotherapy DRUG

Checkpoint inhibitor

Colorectal cancer; NSCLC; Pancreatic cancer

Chemotherapy DRUG

Any form of chemotherapy

Colorectal cancer; Pancreatic cancer; Triple-negative breast cancer

CRC surgical resection PROCEDURE

Surgical resection to remove colorectal cancer

Colorectal cancer

Colonoscopy PROCEDURE

Standard-of-care colonoscopy for CRC screening

High risk for colorectal cancer; Low risk for colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It is anticipated that up to 5000 subjects will be enrolled in this study. It is preferred that enrollment is balanced by sex; however, it is not required. All efforts will be made to provide racial/ethnic balance, with a goal of 20% African American and 10% each of patients with Asian or Hispanic descent.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Persephone Biosciences: lead

Study Sites (10)

Knowledge Research Center

Orange, California, 92866, United States

RECRUITING

SDG Clinical Research, Inc

San Diego, California, 92103, United States

RECRUITING

Persephone Biosciences, Inc.

San Diego, California, 92121, United States

RECRUITING

L&A Morales Healthcare, Inc

Miami, Florida, 33142, United States

RECRUITING

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70809, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Mid-Hudson Medical Research

New Windsor, New York, 12553, United States

RECRUITING

Kroger Health, The Little Clinic

Cincinnati, Ohio, 45202, United States

RECRUITING

Southwest Family Medicine Associates

Dallas, Texas, 75235, United States

RECRUITING

Biopharma Informatic

Houston, Texas, 77089, United States

TERMINATED

Biospecimen

Retention: SAMPLES WITH DNA

Stool and blood samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Triple Negative Breast Neoplasms; Pancreatic Neoplasms; Neoplasms

Interventions

Immunotherapy; Drug Therapy; Colonoscopy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Stephanie Culler, PhD

CONTACT

858-682-4777; support@persephonebiome.com

Stephen Van Dien, PhD

CONTACT

858-682-4777; support@persephonebiome.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: July 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

US (10)