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

Memorial Sloan Kettering Cancer Center13 sites in 2 countries700 target enrollmentOctober 30, 2017

ConditionsPancreatic Cancer Pancreatic Diseases Pancreatitis Pancreatic Cyst

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pancreatic Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 700
Locations: 13
Primary Endpoint: Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 30, 2017

End Date

October 30, 2026

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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

Exclusion Criteria

•Cohort 1: Advanced Pancreatic Cancer Cohort Exclusion Criteria
•Prior chemotherapy or radiation therapy for pancreatic cancer within the last 3 months in the localized setting
•Active second malignancy, unless low grade 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
•Active second malignancy, unless low grade 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