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To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.
The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Borderline Resectable (Cohort A) | Pathological response of Patients with borderline resectable disease (per NCCD Criteria) treated with standard care chemotherapy |
| |
| Patients with Resectable (Cohort B) | Pathological response of Patients with resectable disease (per NCCN criteria) treated with standard care chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | To determine if there are any biomarkers in the blood that could be used to choose best treatment plan for future patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective prediction of pCR in resectable patients | Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended | Up to 2 years |
| Retrospective prediction of pCR in borderline resectable patients | Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended). Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival status | Medical chart will be reviewed for survival status | Up to 2 years |
| RECIST 1.1 response | Tumor response was determined by RECIST1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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community practices and hospital clinics
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christos Fountzilas, MD | Contact | 716-845-2300 | Christos.Fountzilas@roswellpark.org |
| Name | Affiliation | Role |
|---|---|---|
| Christos Fountilas, MD | Roswell Park Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Comprehensive Cancer Center | Recruiting | Buffalo | New York | 14263 | United States | |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| UP to 2 years |
| Good Samaritan University Hospital |
| Recruiting |
| West Islip |
| New York |
| 11795 |
| United States |
|
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |