ARGONAUT: Stool and Blood Sample Bank for Cancer Patients
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| ClinicalTrials.gov Identifier: NCT04638751 |
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Recruitment Status :
Recruiting
First Posted : November 20, 2020
Last Update Posted : February 23, 2021
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Sponsor:
Persephone Biosciences
Information provided by (Responsible Party):
Persephone Biosciences
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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 |
| 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 : | April 2021 |
| 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 |
|---|---|
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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.
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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 |
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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.
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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 |
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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 :
- 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 :
- 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
- 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
- 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
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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
| Contact: Stephanie Culler, PhD | 858-682-4777 | support@persephonebiome.com | |
| Contact: Stephen Van Dien, PhD | 858-682-4777 | support@persephonebiome.com |
Locations
| 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
| 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: | February 23, 2021 |
| Last Verified: | February 2021 |
| 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:
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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 Avelumab Cemiplimab Atezolizumab Antineoplastic Agents Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |