Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Sponsor Columbia University
Collaborator Cold Spring Harbor Laboratory
Start date August 2008
End date December 2016
Trial size 5 participants
Trial identifier NCT01219829, AAAD5381

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients with a strong family history of pancreatic cancer or with a genetic syndrome that puts them at risk for pancreas cancer.
Patients who underwent surgery for pancreatic cancer and developed tumor recurrence after surgery

Primary Outcomes

Measure
Number of subjects with histological features of PanIN lesions assessed
time frame: 1 year

Secondary Outcomes

Measure
Evaluation of clonality multifocal PanIN lesions
time frame: 1 year
Evaluation of Recurrence Mechanism in PDC
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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

Additional Information

Official title Refining the Molecular Progression From Intraductal to Invasive Pancreatic Cancer: Correlating Genetic Profiles and Clinicopathological Phenotypes in Sporadic and Familial Pancreatic Adenocarcinoma
Principal investigator Wendy K Chung, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Columbia University.