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Trial record 1 of 2 for:    Persephone Biosciences
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ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04638751
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Persephone Biosciences

Brief Summary:

ARGONAUT is a longitudinal, prospective, observational study that will enroll up to 4,000 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. 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.

Subjects who meet the entry criteria will provide 2 samples each of blood and stool over a 6-month period. Follow-up appointments will be held at 12, 18, and 24 months to collect tumor scan results and any other updated medical data, with no samples collected.


Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Colorectal Cancer Triple Negative Breast Cancer Pancreas Cancer Drug: Immunotherapy Drug: Chemotherapeutic Agent

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort 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 will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted.
Drug: Immunotherapy
Use of any checkpoint inhibitor to treat a patient that is previously naive to immunotherapy
Other Name: pembrolizumab, nivolumab, ipilimumab, atezolizumab, durvalumab, avelumab, cemiplimab

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: Immunotherapy
Use of any checkpoint inhibitor to treat a patient that is previously naive to immunotherapy
Other Name: pembrolizumab, nivolumab, ipilimumab, atezolizumab, durvalumab, avelumab, cemiplimab

Drug: Chemotherapeutic Agent
Any type of cancer chemotherapy that the patient has not yet been exposed to
Other Name: any

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
Use of any checkpoint inhibitor to treat a patient that is previously naive to immunotherapy
Other Name: pembrolizumab, nivolumab, ipilimumab, atezolizumab, durvalumab, avelumab, cemiplimab

Drug: Chemotherapeutic Agent
Any type of cancer chemotherapy that the patient has not yet been exposed to
Other Name: any

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: Chemotherapeutic Agent
Any type of cancer chemotherapy that the patient has not yet been exposed to
Other Name: any




Primary Outcome Measures :
  1. Determine whether the microbiome composition can predict progression-free survival [ Time Frame: 6-12 months ]
    Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome, and whether there is any correlation with response to treatment


Secondary Outcome Measures :
  1. Identify correlations between microbiome composition and immune markers [ Time Frame: 6-12 months ]
    CyTOF and cytokine analysis will be performed on the blood samples to characterize the patient's immune phenotype

  2. Determine whether the microbiome composition can predict overall survival [ Time Frame: 6-24 months ]
    Survival and tumor progression will be monitored for an extended time beyond sample collection

  3. Build a library of samples and data for future research [ Time Frame: 6-24 months ]
    Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata.


Biospecimen Retention:   Samples With DNA
Stool and blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
It is anticipated that 4000 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.
Criteria

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638751


Contacts
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Contact: Stephanie Culler, PhD 858-682-4777 support@persephonebiome.com
Contact: Stephen Van Dien, PhD 858-682-4777 support@persephonebiome.com

Locations
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United States, California
Persephone Biosciences, Inc. Recruiting
San Diego, California, United States, 92121
Contact: Stephanie Culler, PhD    858-682-4777    support@persephonebiome.com   
Contact: Stephen Van Dien, PhD    858-682-4777    support@persephonebiome.com   
Sponsors and Collaborators
Persephone Biosciences
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Responsible Party: Persephone Biosciences
ClinicalTrials.gov Identifier: NCT04638751    
Other Study ID Numbers: PB-2020-01
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Persephone Biosciences:
microbiome
immunotherapy
checkpoint inhibitor
cancer
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Breast Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Pembrolizumab
Nivolumab
Ipilimumab
Durvalumab
Cemiplimab
Atezolizumab
Antineoplastic Agents
Antineoplastic Agents, Immunological