Autosomal Recessive Polycystic Kidney Disease Clinical Trial
Official title:
The ARPKD Clinical and Genetic Resource (UAB Recessive PKD Research and Translational Core Center)
The University of Alabama at Birmingham Recessive Polycystic Kidney Disease Core Center (UAB
RPKDCC) has established a NIDDK-funded, interdisciplinary center of excellence in
PKD-related research, with specific emphasis on recessive PKD. Among the five Cores, the UAB
RPKDCC includes the ARPKD Clinical and Genetic Resource, a Core resource designed to develop
a unique set of clinical, genetic, and educational resources for ARPKD. The Core has three
primary objectives:
1. To extend the observational study of ARPKD initiated by the North American ARPKD
Database.
2. To provide a mechanism for genetic evaluation of patients with both classic ARPKD and
unusual phenotypes of recessive PKD.
3. To develop educational tools for physicians and patients regarding the natural history,
cause, development and effects of the disease, genetic testing, and clinical trials
applicable to ARPKD.
The Study protocol and the Informed Consent for the Clinical Database will be posted on the
website (http://www.arpkdstudies.uab.edu/) for review by potential participants and
follow-up discussions with the PI and/or Research Nurse Coordinator. In addition, materials
in paper format can be sent to interested potential participants upon request.
Two key elements will be required for patient enrollment: 1) certification that informed
consent has been obtained, and 2) certification that permission for release of selected
health information has also been obtained, including the date of signature. Once receipt of
these items is confirmed, the following actions will proceed:
1. the participant will be assigned a unique identifier in the database and a
clinician-specific web field will be opened for that identifier.
2. the participant/parents will confirm the name of their clinician to the database and
notify their physician and/or genetic counselor (clinicians) of their intent to
participate in this study.
3. the clinician will access the Physician Link on the website, type in the patient name
and the referring center, and if matched to the patient's report, will receive the
unique identifier for that patient. Once this is done, the name of the patient will be
deleted from the online database and only the unique identifier will be used. Each
clinician permitted to access this website will be tracked with a login procedure that
includes a process to verify who is entering the system.
4. This unique identifier will allow the clinician to open the clinical database entry
form and provide the information requested in each field. No names or initials will be
collected in this data form, but gender and date of birth (which will be converted to
age and only the month and year will be kept on file) will be requested.
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Observational Model: Cohort, Time Perspective: Retrospective
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