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2022-07-01
2024-12-31
2025-12-31
5000
NCT04638751
Persephone Biosciences
Persephone Biosciences
OBSERVATIONAL
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 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.
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These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-11-16 | N/A | 2024-04-03 |
2020-11-16 | N/A | 2024-04-05 |
2020-11-20 | N/A | 2024-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
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Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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 | 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 | 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 arrangem | DRUG: Immunotherapy
DRUG: Chemotherapy
PROCEDURE: CRC surgical resection
PROCEDURE: Colonoscopy
|
| : 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 arrangem | 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 ade | 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Identify correlations between microbiome composition and immune markers | CyTOF and cytokine analysis will be performed on the blood samples to characterize the patient's immune phenotype | 6-12 months |
| Determine whether the microbiome composition can predict overall survival | Survival and tumor progression will be monitored for an extended time beyond sample collection | 6-24 months |
| Build a library of samples and data for future research | Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata. | 6-24 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Stephanie Culler, PhD Phone Number: 858-682-4777 Email: support@persephonebiome.com |
Study Contact Backup Name: Stephen Van Dien, PhD Phone Number: 858-682-4777 Email: support@persephonebiome.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
