A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma

Conditions
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Pancreatic Cancer, Pancreatic Diseases, Pancreatitis, Pancreatic Cyst

Intervention / Treatment
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* Diagnostic Test: Blood Draw
* Diagnostic Test: Tumor Tissue Collection
* Diagnostic Test: Cyst Fluid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cohort 1: Advanced Pancreatic Cancer Cohort Inclusion Criteria Radiological, histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution Patient planning to receive systemic treatment Hemoglobin > 8 ECOG performance status 0-2 A minimum age of 18 years old Willing to undergo a tumor biopsy Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). Cohort 2: Operable Pancreatic Cancer Cohort Inclusion Criteria Radiological, histological or cytological confirmed diagnosis of pancreatic adenocarcinoma by the enrolling institution Patient planned to undergo upfront resection No pre-operative systemic therapy nor chemoradiation therapy planned Hemoglobin > 8 ECOG performance status 0-2 A minimum age of 18 years old Willing to undergo a tumor biopsy Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). Cohort 3: Acute Benign Pancreatic Pathology Control Inclusion Criteria Confirmed diagnosis of acute pancreatitis or other acute pancreatic pathology by the enrolling institution Hemoglobin > 8 ECOG performance status 0-2 A minimum age of 18 years old Cohort 4: Chronic Benign Pancreatic Pathology Control Inclusion Criteria Confirmed diagnosis of chronic pancreatitis or other non-cystic chronic pancreatic pathology by the enrolling institution Hemoglobin > 8 ECOG performance status 0-2 A minimum age of 18 years old Cohort 5: IPMN Control Inclusion Criteria Confirmed diagnosis of IPMN without high risk features by the enrolling institution A minimum age of 18 years old Cohort 6: Pancreatic Cyst Control Inclusion Criteria Confirmed diagnosis of benign pancreatic cyst by the enrolling institution A minimum age of 18 years old Cohort 7: Healthy Control Inclusion Criteria A minimum age of 18 years old Exclusion Criteria: Cohort 1: Advanced Pancreatic Cancer Cohort Exclusion Criteria Prior chemotherapy or radiation therapy for pancreatic cancer in any setting Prior history of another malignancy Active second malignancy Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures Cohort 2: Operable Pancreatic Cancer Cohort Exclusion Criteria Neoadjuvant chemotherapy or radiation therapy is planned Prior history of another malignancy, except non-melanoma skin cancer Active second malignancy Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures Cohort 3: Acute Benign Pancreatic Pathology Control Exclusion Criteria Active or prior malignancy, except prior non-melanoma skin cancer Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures Cohort 4: Chronic Benign Pancreatic Pathology Control Exclusion Criteria Active or prior malignancy, except prior non-melanoma skin cancer Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures Cohort 5: IPMN Control Exclusion Criteria IPMN with high risk features or planned resection Active or prior malignancy, except prior non-melanoma skin cancer Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures Cohort 6: Pancreatic Cyst Control Exclusion Criteria Active or prior malignancy, except prior non-melanoma skin cancer Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures Cohort 7: Healthy Control Exclusion Criteria Active or prior malignancy, except prior non-melanoma skin cancer Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Locally Advanced or Metastatic Pancreatic Cancer Cohort<br>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. | Diagnostic Test: Blood Draw<br>* 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 For draw amounts up to 50mL, there is no required hemoglobin threshold. For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period. Patients and controls weighing < 50kg For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.<br>Diagnostic Test: Tumor Tissue Collection<br>* Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere<br>|
| Acute Benign Pancreatic Pathology Control Cohort<br>For patients with acute pancreatitis, blood specimens will be drawn at the time of acute pancreatitis and every 6-12 months thereafter | Diagnostic Test: Blood Draw<br>* 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 For draw amounts up to 50mL, there is no required hemoglobin threshold. For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period. Patients and controls weighing < 50kg For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.<br>Diagnostic Test: Tumor Tissue Collection<br>* Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere<br>|
| Chronic Benign Pancreatic Path,IPMC & Pancreatic Cyst Ctrl<br>For patients with chronic pancreatitis, IPMN, or cysts, blood specimens will be drawn every 6-12 months. | Diagnostic Test: Blood Draw<br>* 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 For draw amounts up to 50mL, there is no required hemoglobin threshold. For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period. Patients and controls weighing < 50kg For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.<br>Diagnostic Test: Tumor Tissue Collection<br>* Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere<br>Diagnostic Test: Cyst Fluid<br>* Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere<br>|
| Healthy Control<br>For normal controls, blood specimens will be drawn once at study baseline. | Diagnostic Test: Blood Draw<br>* 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 For draw amounts up to 50mL, there is no required hemoglobin threshold. For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period. Patients and controls weighing < 50kg For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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17-257