Pancreatic Intraepithelial Neoplasia (PanIN) And The Association With Recurrence Of Pancreatic Adenocarcinoma

Study Overview

Pancreatic Intraepithelial Neoplasia (PanIN) and the Association With Recurrence of Pancreatic Adenocarcinoma

The research purpose of this project is to create a registry, and blood and tissue bank for individuals at high-risk for pancreatic cancer. We plan to conduct histopathological and molecular analysis of resected pancreatic tissue prospectively collected from a cohort of pancreatic cancer patients.

Pancreatic cancer is the fifth leading cause of cancer-related death in the United States. In order to improve outcomes of this disease, significant research efforts have focused on understanding the changes that occur in the pancreas prior to tumor occurrence. The types of changes most often associated with tumor have been named pancreatic intraepithelial neoplasia (PanIN). It is not yet clear how to identify the PanIN lesions most likely to develop into cancer and the length of time required for this progression. In order to evaluate these questions, we are interested in examining the microscopic and genetic characteristics of PanIN lesions in two "high-risk" patients: 1) patients who underwent surgery for pancreatic cancer and developed tumor recurrence after surgery and 2) patients with a strong family history of pancreatic cancer or with a genetic syndrome that puts them at risk for pancreas cancer. The surgical specimens from these patients will be evaluated by a pathologist for evidence of widespread PanIN lesions. In addition, PanIN lesions will be tested for abnormalities in several major genes that are known to be important in pancreatic cancer.

Pancreatic Cancer

AAAD5381

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-10-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-06-09
First Submitted that Met QC Criteria 2010-10-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-06-11
First Posted (ACTUAL) 2010-10-13	Results First Posted N/A	Last Verified 2021-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Family History patients Patients with a strong family history of pancreatic cancer or with a genetic syndrome that puts them at risk for pancreas cancer.
: Recurrence patients Patients who underwent surgery for pancreatic cancer and developed tumor recurrence after surgery

Primary Outcome Measures	Measure Description	Time Frame
Number of subjects with histological features of PanIN lesions assessed	Distinctive histological features of PanIN within surgical specimens of our two study groups will be assessed by pathologists.	1 year

Secondary Outcome Measures	Measure Description	Time Frame
Evaluation of clonality multifocal PanIN lesions	Using microarray-based comparative genomic hybridization (aCGH) to evaluate the samples.	1 year
Evaluation of Recurrence Mechanism in PDC	aCGH will also be utilized to evaluate recurrence mechanism in a set of cases in which both original tumor and recurrence tumor was resected, allowing for clonal origins to be evaluated.	1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Tissue-confirmed diagnosis of pancreatic adenocarcinoma.
Underwent surgical resection for adenocarcinoma at Columbia-Presbyterian Medical Center with pathologically negative surgical margins.
Enrolled in our Pancreatic Cancer Registry and Tissue Bank protocol (AAAA-6154).
Have at least 2 relatives (of whom one must be first-degree relative) with pancreatic cancer, or have been diagnosed with a a genetic syndrome which is associated with pancreatic cancer (among the included syndromes include BRCA1/2, FAMMM, Peutz-Jeghers, HNPCC, Hereditary Pancreatitis) -OR- Have radiological or pathological (fine needle aspirate or surgical biopsy) evidence of local tumor recurrence following surgery.

Metastatic disease discovered at presentation or on recurrence (exception is the familial PDC patients)
Positive surgical margins.
Lack of clinical followup at one year following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Cold Spring Harbor Laboratory

Investigators

PRINCIPAL_INVESTIGATOR: Wendy K Chung, MD, Columbia University

Publications

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General Publications

No publications available

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