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International Registry for Intraductal Papillary Mucinous Neoplasma

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ClinicalTrials.gov Identifier: NCT00828048
Recruitment Status : Active, not recruiting
First Posted : January 23, 2009
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Michele D. Lewis, M.D., Mayo Clinic

Brief Summary:
A centralized web-based database will be used to track patients with IPMN lesions of the pancreas to study natural history and risk factors for malignant transformation in this multi-center study.

Condition or disease
Pancreatic Cysts

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 560 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: International Registry for Intraductal Papillary Mucinous Neoplasma
Study Start Date : March 2008
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Group/Cohort
Pancreatic Cyst
Pancreatic Cyst



Primary Outcome Measures :
  1. 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 ]
    Size and growth pattern of pancreas cysts, presence of mural nodules, development of solid tumor or malignancy will be tracked over time, based on imaging studies including EUS, MRI or CT as clinically indicated.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828048


Locations
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michele D Lewis, MD Mayo Clinic

Responsible Party: Michele D. Lewis, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00828048     History of Changes
Other Study ID Numbers: 07-007845
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

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