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NCT04638751 · ClinicalTrials.gov registry record

ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

A clinical trial of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Persephone Biosciences.

Recruiting
Registry status
5,000
Enrollment target
10
Study locations

NCT04638751 is a study of Non-Small Cell Lung Cancer and Colorectal Cancer that is actively recruiting participants, run by Persephone Biosciences. The registered enrollment target is 5,000 participants, above the 648-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (672% higher). The trial reports 10 study locations across 6 states.

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The verdict

NCT04638751, a study of Non-Small Cell Lung Cancer and Colorectal Cancer, is actively recruiting participants, sponsored by Persephone Biosciences.

RECRUITING
Registry status
5,000 participants
Enrollment target
10
Study locations

Study 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

  • PROCEDURE Colonoscopy
  • DRUG Chemotherapy
  • DRUG Immunotherapy
  • PROCEDURE CRC surgical resection

Study Locations (10)

California

  • Knowledge Research Center - Orange
  • SDG Clinical Research, Inc - San Diego
  • Persephone Biosciences, Inc. - San Diego

Louisiana

  • Baton Rouge General Medical Center - Baton Rouge
  • University Medical Center New Orleans - New Orleans

Texas

  • Southwest Family Medicine Associates - Dallas
  • Biopharma Informatic - Houston

Florida

  • L&A Morales Healthcare, Inc - Miami

New York

  • Mid-Hudson Medical Research - New Windsor

Ohio

  • Kroger Health, The Little Clinic - Cincinnati

Trial Details

FieldValue
Enrollment Target 5,000 participants
Start Date 2022-07-01
Est. Completion 2025-12-31

Sponsor

Persephone Biosciences

6 total trials

What the Registry Record Tells You About NCT04638751

The ClinicalTrials.gov registry entry for NCT04638751 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 5,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 648-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (672% higher). The listed sponsor is Persephone Biosciences, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Colonoscopy is the first listed.

NCT04638751 reports 10 study locations spanning 6 distinct geographic areas - top geographies include California, Louisiana, Texas.

Frequently Asked Questions

What is clinical trial NCT04638751 about?

NCT04638751 is a clinical study titled "ARGONAUT: Stool and Blood Sample Bank for Cancer Patients". 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 guid...

What is the current status of trial NCT04638751?

This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 2022-07-01. Estimated completion is 2025-12-31.

What conditions does trial NCT04638751 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Pancreas Cancer.

What interventions are being tested in trial NCT04638751?

The interventions under investigation include: Colonoscopy (PROCEDURE), Chemotherapy (DRUG), Immunotherapy (DRUG), CRC surgical resection (PROCEDURE).

Who is sponsoring clinical trial NCT04638751?

This trial is sponsored by Persephone Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04638751 being conducted?

This trial has 10 study locations across California, Florida, Louisiana, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.