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| Name | Class |
|---|---|
| Sheba Medical Center | OTHER_GOV |
| Weill Medical College of Cornell University | OTHER |
| Weizmann Institute of Science | OTHER |
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The purpose of this study is to develop a minimally invasive test to diagnose pancreatic cancer at early stages of disease and monitor response to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Locally Advanced or Metastatic Pancreatic Cancer Cohort | For patients with locally advanced or metastatic PDAC, blood will be collected pre-treatment initiation (baseline), after first chemotherapy cycle, every 8-12 weeks while under treatment to coincide with restaging CT scan and at time of disease progression. |
| |
| Acute Benign Pancreatic Pathology Control Cohort | For patients with acute pancreatitis, blood specimens will be drawn at the time of acute pancreatitis and every 6-12 months thereafter |
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| Chronic Benign Pancreatic Path,IPMC & Pancreatic Cyst Ctrl | For patients with chronic pancreatitis, IPMN, or cysts, blood specimens will be drawn every 6-12 months. |
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| Healthy Control | For normal controls, blood specimens will be drawn once at study baseline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Diagnostic Test | If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria: Patients and controls weighing 50kg or more
Patients and controls weighing < 50kg
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| Measure | Description | Time Frame |
|---|---|---|
| Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer | 4 years |
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Inclusion Criteria:
Cohort 1: Advanced Pancreatic Cancer Cohort Inclusion Criteria
Cohort 2: Operable Pancreatic Cancer Cohort Inclusion Criteria
Cohort 3: Acute Benign Pancreatic Pathology Control Inclusion Criteria
Cohort 4: Chronic Benign Pancreatic Pathology Control Inclusion Criteria
Cohort 5: IPMN Control Inclusion Criteria
Cohort 6: Pancreatic Cyst Control Inclusion Criteria
Cohort 7: Healthy Control Inclusion Criteria
Exclusion Criteria:
Cohort 1: Advanced Pancreatic Cancer Cohort Exclusion Criteria
Cohort 2: Operable Pancreatic Cancer Cohort Exclusion Criteria
Cohort 3: Acute Benign Pancreatic Pathology Control Exclusion Criteria
Cohort 4: Chronic Benign Pancreatic Pathology Control Exclusion Criteria
Cohort 5: IPMN Control Exclusion Criteria
Cohort 6: Pancreatic Cyst Control Exclusion Criteria
Cohort 7: Healthy Control Exclusion Criteria
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Potential research subjects in the PDAC and benign pancreatic disease cohorts will be identified by a member of the patient's treatment team, the principal investigator, or research team at participating institutions. If the investigator is a member of the treatment team, s/he will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. The investigator will use information provided by the patient and/or medical record to confirm that the patient is eligible and contact the patient regarding study enrollment. Healthy controls will be recruited from patients from outpatient primary care clinics at non-MSK sites and volunteers from which may include the staffs members at collaborating sites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Yu, MD | Contact | 646-888-4188 | yuk1@mskcc.org | |
| David Kelson, MD | Contact | 646-888-4179 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Monmouth (All protocol activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Blood samples will be analyzed for various biomarkers. Initial biomarkers to be tested include proteins and proteases, functional DNA repair assays, exosomes, stromal elements, circular RNAs (cRNA) and circulating tumor DNA (ctDNA).
Tissue will be utilized from already planned. Biopsy tissue is expected to be available for virtually all PDAC patients, occasionally for IPMN and cysts patients, rarely for pancreatitis and never for healthy controls.
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| Tumor Tissue Collection | Diagnostic Test | Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere |
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| Cyst Fluid | Diagnostic Test | Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere |
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| Memorial Sloan Kettering Bergen (All protocol activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Cold Springs Harbor Laboratory (Specimen Analysis) | Not yet recruiting | Cold Spring Harbor | New York | 11724 | United States |
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| Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (All protocol activities) | Recruiting | Harrison | New York | 10604 | United States |
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| New York University | Active, not recruiting | New York | New York | 10010 | United States |
| Memorial Sloan - Kettering Cancer Center | Recruiting | New York | New York | 10021 | United States |
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| Memorial Sloan Kettering Basking Ridge (All protocol activities) | Recruiting | New York | New York | 10065 | United States |
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| Weill Cornell Medical Center | Not yet recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau (All protocol activities) | Recruiting | Rockville Centre | New York | 11553 | United States |
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| Sha'are Zedek Medical Center | Not yet recruiting | Jerusalem | 91031 | Israel |
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| Weizmann Institute of Science | Not yet recruiting | Rehovot | Israel |
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| Sheba Medical Center | Recruiting | Tel Litwinsky | Israel |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010182 | Pancreatic Diseases |
| D010195 | Pancreatitis |
| D010181 | Pancreatic Cyst |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D004700 | Endocrine System Diseases |
| D003560 | Cysts |
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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 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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