Family and Personal History of Malignancy in Intraductal Papillary Mucinous Neoplasm (IPMN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wendy K. Chung, Columbia University
ClinicalTrials.gov Identifier:
NCT01104077
First received: April 13, 2010
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

Intraductal papillary mucinous neoplasm (IPMN) is a cyst-like cancer of the pancreas that is increasingly being identified in medical practice, including during the screening of individuals at high risk of pancreatic cancer. It has been established that 10 to 20% of pancreatic cancers are familial. In comparison, there has been little research into the importance of genetic risk in IPMN incidence. The investigators will perform a retrospective chart review of patients with IPMN who were evaluated for surgical intervention at our tertiary referral center. The investigators are interested in determining the proportion of IPMN patients with a family history of pancreatic and other cancers. In addition, the investigators will assess if familial cancer risk is associated with increased risk for malignant IPMN and recurrence, relative to those patients without an inherited predisposition.

The investigators hypothesize that 10 to 20% of patients with intraductal papillary mucinous neoplasm (IPMN) will have an underlying genetic predisposition, as evidenced by a family history of pancreatic cancer or other malignancies. The investigators further hypothesize that, compared to IPMN patients without a family history of pancreatic cancer and/or other malignancies, patients with a family history will be more likely to have IPMN subtypes of higher malignant potential (main duct or mixed type location) and more advanced histology (carcinoma in situ or invasive carcinoma), and will have a higher recurrence rate following surgical resection.


Condition
Pancreatic Cancer
Neoplasm

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Family and Personal History of Pancreatic and Other Malignancies in Patients With Intraductal Papillary Mucinous Neoplasms

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Percentage of patients with relatives with pancreatic cancer or IPMN [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    Extent of Family History: The primary outcome will be the percentage of IPMN patients with at least one first-degree relative with pancreatic cancer or IPMN, or at least two first or second degree relatives with pancreatic cancer, IPMN, or malignancies related to pancreatic cancer syndromes, including colorectal, gastric, breast, ovarian, and melanoma neoplasms.


Secondary Outcome Measures:
  • Relative Risk of IPMN subtypes [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    Characteristics of IPMN patients with Family History: Secondary outcomes will be the relative risk of IPMN subtypes of higher malignant potential (main duct or mixed type location), more advanced histology (carcinoma in situ or invasive carcinoma), and recurrence following surgical resection amongst subjects with a family history.


Estimated Enrollment: 156
Study Start Date: November 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Detailed Description:

This is a retrospective observational study to determine the proportion of patients with a family history of pancreatic cancer and other malignancies among patients who have intraductal papillary mucinous neoplasm (IPMN).

The investigators will be reviewing the demographic, clinical, radiologic, pathologic, and follow-up information from the Pancres Center database. The investigators will also conduct a chart review to collect information recorded by clinicians on each subject's family history of malignancy and personal history of malignancy. Results of this database and chart review will be incorporated into a datasheet in which all patient identifiers have been removed.

The primary outcome will be the percentage of IPMN patients with at least one first-degree relative with pancreatic cancer or IPMN, or at least two first or second degree relatives with pancreatic cancer, IPMN, or malignancies related to pancreatic cancer syndromes, including colorectal, gastric, breast, ovarian, and melanoma neoplasms. Data will be compared using the chi-squared test. Secondary outcomes will be the relative risk of IPMN subtypes of higher malignant potential (main duct or mixed type location), more advanced histology (carcinoma in situ or invasive carcinoma), and recurrence following surgical resection amongst subjects with a family history. Secondary outcomes will be assessed by univariate analysis using the t test and by multivariate analysis.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients seen at Columbia University Medical Center's Pancreas Center who have been diagnosed with intraductal papillary mucinous neoplasm, a cystic neoplasm of the pancreatic duct that has malignant potential.

Criteria

Inclusion Criteria:

  • Tissue-confirmed diagnosis of intraductal papillary mucinous neoplasm or imaging suspicious for IPMN
  • Seen in consultation for IPMN at Columbia-Presbyterian Medical Center between 2002 and 2008

Exclusion Criteria:

  • None
  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: NCT01104077

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

No publications provided

Responsible Party: Wendy K. Chung, Assistant Professor of Pediatrics, Molecular Genetics, Columbia University
ClinicalTrials.gov Identifier: NCT01104077     History of Changes
Other Study ID Numbers: AAAD6106
Study First Received: April 13, 2010
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Pancreatic Cancer
Family History
Pre-cancerous lesion
Intraductal Papillary Mucinous Neoplasm (IPMN)
Intraductal Papillary Mucinous Neoplasm

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014