Family and Personal History of Malignancy in Intraductal Papillary Mucinous Neoplasm (IPMN)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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, we 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 |
- Primary outcome: Extent of Family History [ Time Frame: 20 years ] [ Designated as safety issue: No ]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: Characteristics of IPMN patients with Family History [ Time Frame: 20 years ] [ Designated as safety issue: No ]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: | September 2008 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| 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, AAAD-6106 |
| Study First Received: | April 13, 2010 |
| Last Updated: | July 2, 2012 |
| 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 May 19, 2013