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

NCT01104077 | Completed DMC

• 1 other identifier: AAAD6106
• Study Type: observational
• Target: 277
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Pancreatic Cancer; Neoplasm

Keywords

Pancreatic Cancer; Family History; Pre-cancerous lesion; Intraductal Papillary Mucinous Neoplasm (IPMN); Intraductal Papillary Mucinous Neoplasm

Outcome Measures

Primary Outcomes (1)

• Percentage of IPMN patients with relatives with pancreatic cancer or IPMN

  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.

  20 years

Secondary Outcomes (1)

• Percentage of IPMN patients exhibiting higher malignant potential or recurrence following surgical resection

  20 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Wendy K Chung, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: November 17, 2008
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)