Clinical trial NCT00792155: Polycystic Kidney Disease Data Repository
Official title: Autosomal Dominant Polycystic Kidney Disease Data Repository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Kidney Disease
Keywords: PKD
Lead sponsor: The Rogosin Institute
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: New York Presbyterian Hospital
First posted: 2008-11-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients enrolled in this study will have the diagnosis of autosomal dominant kidney disease. The diagnostic criteria for at-risk individuals (i.e., with a first degree family member with ADPKD) includes the presence of at least two(unilateral or bilateral) renal cysts, and two cysts in each kidney are considered sufficient for diagnosis in aged 15 to 29 years and in 30 to 59 years, respectively. In families of unknown genotype, the presence of three or more (unilateral or bilateral) renal cysts is sufficient for establishing the diagnosis in individuals aged 15 to 39 years, two or more cysts in each kidney is sufficient for individuals aged 40-59 years and four or more cysts in each kidney is required in individuals ≥60 years of age.

Brief summary: Autosomal dominant polycystic kidney disease (PKD) is the most common inherited kidney disease, affecting more than 400,000 people in the U.S. and 5 million people worldwide. PKD is the 4th most common cause of kidney failure requiring dialysis and/or transplantation. Over half of all PKD patients develop kidney failure by age 60 years, although age of onset of kidney disease varies widely, even among members of the same family.

Despite the fact this is a relatively common problem, relatively few patients have been studied for a sufficient period of time to fully understand how patients are affected over the course of their lifetime. The reason for creating this repository is to collect information about PKD so that the investigators may fully understand its complications, including high blood pressure, heart attack, and stroke. This information may also aid in the development of improved treatment strategies.

Detailed description: Visit #1:

* An initial detailed history, physical examination, and laboratory evaluation
* An extensive family history of PKD will be obtained from the patient.

Follow-up Study Visits:

- Patients will return to the outpatient facility for detailed follow-up examinations every other year after Visit 1.

Eligibility criteria: Inclusion Criteria:

* Any person, age 18 or older, with previously diagnosed ADPKD is eligible to participate.

Exclusion Criteria:

* Inability to provide informed consent.

Primary outcomes:
measure: Polycystic kidney disdease data repository
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
Study officials:
affiliation: The Rogosin Institute
name: Jon Blumenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goel A, Shih G, Riyahi S, Jeph S, Dev H, Hu R, Romano D, Teichman K, Blumenfeld JD, Barash I, Chicos I, Rennert H, Prince MR. Deployed Deep Learning Kidney Segmentation for Polycystic Kidney Disease MRI. Radiol Artif Intell. 2022 Feb 16;4(2):e210205. doi: 10.1148/ryai.210205. eCollection 2022 Mar.