CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 623 enrolled
Drug / intervention
Blood sample +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03672422
NCT03672422N/ACompleted

Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) CPDPC16-03 Pediatric Longitudinal Cohort Study of Chronic Pancreatitis

Aliye Uc·observational·Posted Sep 14, 2018·Updated Nov 6, 2020

In Brief

An observational study evaluating Blood sample, Patient questionnaires, and 2 other interventions for Pancreatitis, Chronic and Pancreatitis, Acute. Completed, enrolled 623 participants across 22 sites in 4 countries.

Detailed Summary

The investigators will enroll a total of 628 patients under 18 years of age with ARP or CP. Included in the total are the 357patients in the INSPPIRE 1 database who are planned to be reenrolled under this protocol over the next 4 years. Patient questionnaires and physician surveys will be applied at the time of enrollment and annually thereafter as long as possible. At the first study visit after turning 18 years of age, the patient will sign the informed consent to continue in the study. Specifically, the investigators will define the demographics of the pediatric ARP and CP cohort, describe risk factors, presence of family history of acute and chronic pancreatitis, diabetes and pancreatic cancer and assess disease burden and sequelae.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Israel, United States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 14, 2018
Enrollment StartJun 30, 2017
Primary CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.8 years ago

Interventions

Blood sampleother

Six ml of blood will be collected from patients in an EDTA tube. 2 ml saliva samples in Oragene DNA collection kits

Patient questionnairesbehavioral

Questionnaires will be completed at the baseline and annual follow-up visits to collect data that will define the demographics of the pediatric ARP and CP cohort, describe risk factors, presence of family history of acute and chronic pancreatitis, diabetes and pancreatic cancer and assess disease burden and sequelae.

Saliva sampleother

2 ml saliva samples in Oragene DNA collection kits collected if no blood sample being collected.

Urine sampleother

50 ml of urine in collection container.