International Registry for Intraductal Papillary Mucinous Neoplasma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Mayo Clinic
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00828048
First received: January 21, 2009
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

Intraductal papillary mucinous neoplasms of the pancreas (IPMN) are increasingly recognized in clinical practice. They represent a unique clinicopathologic entity that is characterized by mucin production, cystic dilation of the pancreatic ducts, and intraductal papillary growth. The World Health Organization recognized IPMN as a distinct clinical entity in 1996. Recent literature suggests that up to 45% of IPMN are malignant and should be resected; however these data are based on larger, primarily symptomatic lesions. Several studies have been published in the recent literature reporting single-center experience with IPMN resections and observations with small numbers of patients. The natural history of these lesions and risk of malignancy is still vague. Consensus guidelines for management of IPMN were published in 2006, but noted the limited knowledge available in six areas: definition and classification, preoperative evaluation, indication for resection, method of resection, histological data on frozen section/positive margins and specimen processing, and finally, method of follow-up. Speaking to this need, we propose an international registry for multi-center collaboration in the above areas of need in IPMN research and clinical management. This will be through a centralized, web-based registry with data entered by each center in a de-identified way to protect confidentiality.

The data collected from the IRB approved retrospective chart review IRB# 07-007202 will be incorporated into this data base. Any patients that participate in the prospective study will be consented with HIPPA consent prior to collection of data.


Condition
Pancreatic Cysts

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: International Registry for Intraductal Papillary Mucinous Neoplasma

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Identify clinical and morphological predictors of cancer or high grade dysplasia in patients with IPMN. Identify predictors of progression to cancer or high grade dysplasia among patients who are followed in surveillance programs. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • We plan to pilot test the database at the host site MCJ, then roll-out to the remaining external sites. [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 560
Study Start Date: March 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pancreatic Cyst
Pancreatic Cyst

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care

Criteria

Inclusion Criteria:

  • Suspected IPMN based on the consensus guidelines (7)
  • Endoscopic ultrasound imaging at baseline examination
  • Either surgical histology or clinical follow up with EUS, MRI, or CT scan for at least 1 year
  • Cases previously collected that meet the above criteria will be allowed

Exclusion Criteria:

  • Patients who do not meet the above inclusion criteria
  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: NCT00828048

Contacts
Contact: Verna A. Skinner, CCRP 904-953-8982 skinner.verna@mayo.edu

Locations
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Verna A. Skinner, CCRP    904-953-8982    skinner.verna@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michele D Lewis, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Michele D. Lewis, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00828048     History of Changes
Other Study ID Numbers: 07-007845
Study First Received: January 21, 2009
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Cyst
Cysts
Neoplasms
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014