A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03334708

Collaborator

Sheba Medical Center (Other), Weill Medical College of Cornell University (Other), Weizmann Institute of Science (Other)

700

Enrollment

Locations

Anticipated Duration (Months)

53.8

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Pancreatic Diseases Pancreatitis Pancreatic Cyst	Diagnostic Test: Blood Draw Diagnostic Test: Tumor Tissue Collection Diagnostic Test: Cyst Fluid

Study Design

Study Type:

Observational

Anticipated Enrollment :

700 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 30, 2017

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Diagnostic Test: Blood Draw 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. Diagnostic Test: Tumor Tissue Collection Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
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	Diagnostic Test: Blood Draw 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. Diagnostic Test: Tumor Tissue Collection Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
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.	Diagnostic Test: Blood Draw 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. Diagnostic Test: Tumor Tissue Collection Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere Diagnostic Test: Cyst Fluid Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Healthy Control For normal controls, blood specimens will be drawn once at study baseline.	Diagnostic Test: Blood Draw 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.

Outcome Measures

Primary Outcome Measures

Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Cohort 1: Advanced Pancreatic Cancer Cohort Inclusion Criteria

Histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution
Patient planning to receive systemic treatment
For stage IV patients, if adjuvant chemotherapy and/or chemoradiation therapy was received for AJCC Stage I-III pancreatic adenocarcinoma, patients are eligible if the last systemic therapy was given more than 6 months before initiation of currently planned systemic therapy
Hemoglobin > 8
ECOG performance status 0-2
A minimum age of 18 years old
Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). New tumor biopsies are not required for entrance into the protocol.

Cohort 2: Operable Pancreatic Cancer Cohort Inclusion Criteria

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 provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). New tumor biopsies are not required for entrance into the protocol.

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 therapy for advanced/metastatic disease
Prior history of another malignancy
Adjuvant therapy for resected disease within the last 6 months
Active second malignancy
Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer

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
Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Monmouth (All protocol activities)	Middletown	New Jersey	United States	07748
2	Memorial Sloan Kettering Bergen (All protocol activities)	Montvale	New Jersey	United States	07645
3	Cold Springs Harbor Laboratory (Specimen Analysis)	Cold Spring Harbor	New York	United States	11724
4	Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)	Commack	New York	United States	11725
5	Memoral Sloan Kettering Westchester (All protocol activities)	Harrison	New York	United States	10604
6	New York University	New York	New York	United States	10010
7	Memorial Sloan - Kettering Cancer Center	New York	New York	United States	10021
8	Memoral Sloan Kettering Basking Ridge (All protocol activitie)	New York	New York	United States	10065
9	Weill Cornell Medical Center	New York	New York	United States	10065
10	Memorial Sloan Kettering Nassau (All protocol activities)	Rockville Centre	New York	United States	11553
11	Sha'are Zedek Medical Center	Jerusalem		Israel	91031
12	Weizmann Institute of Science	Reẖovot		Israel
13	Sheba Medical Center	Tel Hashomer		Israel