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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cold Spring Harbor Laboratory
Information provided by (Responsible Party):
Wendy K. Chung, Columbia University
ClinicalTrials.gov Identifier:
NCT01219829
First received: October 11, 2010
Last updated: June 10, 2016
Last verified: June 2016
  Purpose
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.

Condition
Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Refining the Molecular Progression From Intraductal to Invasive Pancreatic Cancer: Correlating Genetic Profiles and Clinicopathological Phenotypes in Sporadic and Familial Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Number of subjects with histological features of PanIN lesions assessed [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Distinctive histological features of PanIN within surgical specimens of our two study groups will be assessed by pathologists.


Secondary Outcome Measures:
  • Evaluation of clonality multifocal PanIN lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Using microarray-based comparative genomic hybridization (aCGH) to evaluate the samples.

  • Evaluation of Recurrence Mechanism in PDC [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA
  • Blood samples
  • Specimens of tumors, pre-cancerous lesions, and normal tissue from patients who need to have endoscopy or surgery for diagnosis or treatment of tumors that develop
  • Samples of urine and stool, and duodenal aspirates if an individual will be having an endoscopy

Estimated Enrollment: 5
Study Start Date: August 2008
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219829

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Cold Spring Harbor Laboratory
Investigators
Principal Investigator: Wendy K Chung, MD Columbia University
  More Information

Responsible Party: Wendy K. Chung, Assistant Professor of Pediatrics, Molecular Genetics, Columbia University
ClinicalTrials.gov Identifier: NCT01219829     History of Changes
Other Study ID Numbers: AAAD5381 
Study First Received: October 11, 2010
Last Updated: June 10, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Columbia University:
Pancreatic intraepithelial neoplasia (PanIN)
Pancreatic Cancer
Recurrence of pancreatic cancer
Field Effect
Genetic mutations in pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 27, 2016