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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy | Drug | Checkpoint inhibitor |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Culler, PhD | Contact | 858-682-4777 | support@persephonebiome.com | |
| Stephen Van Dien, PhD | Contact | 858-682-4777 | support@persephonebiome.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knowledge Research Center | Recruiting | Orange | California | 92866 | United States |
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Stool and blood samples
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| 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). |
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| 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. |
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| Chemotherapy | Drug | Any form of chemotherapy |
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| CRC surgical resection | Procedure | Surgical resection to remove colorectal cancer |
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| Colonoscopy | Procedure | Standard-of-care colonoscopy for CRC screening |
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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 |
| SDG Clinical Research, Inc | Recruiting | San Diego | California | 92103 | United States |
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| Persephone Biosciences, Inc. | Recruiting | San Diego | California | 92121 | United States |
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| L&A Morales Healthcare, Inc | Recruiting | Miami | Florida | 33142 | United States |
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| Baton Rouge General Medical Center | Recruiting | Baton Rouge | Louisiana | 70809 | United States |
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| University Medical Center New Orleans | Recruiting | New Orleans | Louisiana | 70112 | United States |
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| Mid-Hudson Medical Research | Recruiting | New Windsor | New York | 12553 | United States |
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| Kroger Health, The Little Clinic | Recruiting | Cincinnati | Ohio | 45202 | United States |
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| Southwest Family Medicine Associates | Recruiting | Dallas | Texas | 75235 | United States |
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| Biopharma Informatic | Terminated | Houston | Texas | 77089 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D004358 | Drug Therapy |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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