Clinical trial NCT01219829: Pancreatic Intraepithelial Neoplasia (PanIN) and the Association With Recurrence of Pancreatic Adenocarcinoma
Official title: Refining the Molecular Progression From Intraductal to Invasive Pancreatic Cancer: Correlating Genetic Profiles and Clinicopathological Phenotypes in Sporadic and Familial Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: Pancreatic intraepithelial neoplasia (PanIN)
Pancreatic Cancer
Recurrence of pancreatic cancer
Field Effect
Genetic mutations in pancreatic cancer
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Cold Spring Harbor Laboratory
First posted: 2010-10-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are identified by a clinician as having either 1) a strong family history of pancreatic cancer; or 2) evidence (radiological or pathological) of local tumor recurrence following surgical resection, will be included in the study.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with histological features of PanIN lesions assessed
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of clonality multifocal PanIN lesions
timeFrame: 1 year
measure: Evaluation of Recurrence Mechanism in PDC
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Wendy K Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: