NCT00004475

Brief Summary

The purpose of this study is to establish linkage in families with hereditary pancreatitis (HP) to the cationic trypsinogen gene or other, as yet unknown, HP gene(s).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
808

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 1998

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

December 1, 1998

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
23.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

24 years

First QC Date

October 18, 1999

Last Update Submit

August 10, 2023

Conditions

Pancreatitis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Diagnosis of hereditary pancreatitis with confirmation of phenotype by: Onset of pain before age 20 Amylase elevation at least 2 times normal Surgical or postmortem confirmation of pancreatitis Unequivocal evidence of pancreatic exocrine insufficiency in the absence of trauma, alcohol abuse, elevated serum lipids, or other known causes * Family member of a patient diagnosed with hereditary pancreatitis

You may qualify if:

  • Diagnosis of pancreatitis at age \< 60 OR
  • Diagnosis of pancreatitis at any age and at least one other 1st or 2nd degree relative with a diagnosis of pancreatitis or pancreatic cancer OR
  • Diagnosis of pancreatic cancer and a 1st or 2nd degree relative with pancreatic cancer or pancreatitis OR
  • Diagnosis of pancreatic insufficiency or maldigestion that improves with pancreatic enzyme replacement OR
  • Close family members (parents, grandparents, siblings cousins - anyone related by blood) of subjects who meet criteria 1, 2, or 3 AND
  • Age 3 months up to 100 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh, Presbyterian University Hospital

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood or saliva samples are collected from patients and family members. DNA is extracted and used for genotypic analysis.

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • David C. Whitcomb

    University of Pittsburgh

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

December 1, 1998

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

US(1)