NCT00828048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

11.7 years

First QC Date

January 21, 2009

Last Update Submit

November 4, 2019

Conditions

Pancreatic Cysts

Outcome Measures

Primary Outcomes (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.

    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.

    End of study

Study Arms (1)

Pancreatic Cyst

Pancreatic Cyst

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Officials

  • Michele D Lewis, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 23, 2009

Study Start

March 1, 2008

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

November 6, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)