RECRUITING

Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a longitudinal natural history study of Infantile Pompe disease. The investigators will regularly collect and review medical information regarding the diagnosis of Pompe disease, response to enzyme replacement (ERT) using alglucosidase alfa (Lumizyme/Myozyme) and response to immunosuppressive therapy in cases at risk for developing or those who have developed high and sustained antibodies to ERT. To follow the long-term outcomes, we will collect medical records including but not limited to the diagnosis, clinical parameters, assessments for clinical monitoring, and laboratory values including antibody testing results.

Official Title

Determination of Cross-Reactive Immunological Material (CRIM) Status and Longitudinal Follow-up of Individuals With Pompe Disease

Quick Facts

Study Start:2009-09
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01665326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of infantile, atypical or juvenile onset Pompe disease
  2. * Must provide a written informed consent
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Ankit K Desai, MBBS
CONTACT
919-613-6310
ankit.desai@duke.edu
Eleanor Rodriguez-Rassi, MPH
CONTACT
919-613-1219
eleanor.rodriguezrassi@duke.edu

Principal Investigator

Priya S Kishnani, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Priya S Kishnani, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2009-09
Study Completion Date2025-03

Study Record Updates

Study Start Date2009-09
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • Pompe disease
  • Glycogen Storage Disease Type II
  • Acid Maltase Deficiency
  • CRIM Status
  • Acid Alpha-Glucosidase Deficiency
  • Alglucosidase alfa
  • Myozyme
  • Enzyme replacement therapy
  • Immune Tolerance Induction
  • Lumizyme
  • Immunomodulation
  • Anti-drug antibodies

Additional Relevant MeSH Terms

  • Pompe Disease