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Pediatric Longitudinal Cohort Study of Chronic Pancreatitis

NCT03672422 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 623

Last updated 2020-11-06

No results posted yet for this study

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.

Conditions

  • Pancreatitis, Chronic
  • Pancreatitis, Acute

Interventions

DIAGNOSTIC_TEST

Blood sample

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

BEHAVIORAL

Patient questionnaires

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.

DIAGNOSTIC_TEST

Saliva sample

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

DIAGNOSTIC_TEST

Urine sample

50 ml of urine in collection container.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Aliye Uc

    lead OTHER

Principal Investigators

  • Ying Yuan, Ph.D · MD Anderson

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • United States
  • Australia
  • Canada
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03672422 on ClinicalTrials.gov