Establishment of a Database for Long-Term Monitoring of P... | NCT00004312

Studies
Establishment of a Database for Long-Term Monitoring of Patients With Nephropathic Cystinosis

NCT00004312

Sponsor

National Center for Research Resources (NCRR)

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

400

Phase

Not provided

Conditions

Cystinosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2003

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1999

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 18, 1999

First Submission Date that Met QC Criteria

Oct 18, 1999

First Posted Date

Oct 19, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Center for Research Resources (NCRR)NIH

Collaborators

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH
University of California, San Diego	OTHER

Description Module

Brief Summary

OBJECTIVES: I. Establish a computerized databank to monitor the progress of patients with cystinosis treated with cysteamine.

II. Track and monitor all patients including renal transplant, dialysis and post renal transplants.

Detailed Description

PROTOCOL OUTLINE:

Data are collected from patients and physicians. Information includes disease, treatment, family history, demographic, and physical exam data. The dates of kidney transplantation and/or dialysis initiation are also recorded.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

400

Eligibility Module

Eligibility Criteria

PROTOCOL ENTRY CRITERIA:

Nephropathic cystinosis diagnosis by white-cell cystine measurement, including infantile and late-onset forms

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jerry A. Schneider	University of California, San Diego	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Diego School of Medicine		La Jolla	California	92093-0652	United States

Condition Browse Module

MeSH Terms

ID	Term
D003554	Cystinosis
D035583	Rare Diseases
D000091642	Urogenital Diseases

Ancestor Terms

ID	Term
D016464	Lysosomal Storage Diseases
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
UCSD-970026
UCSD-950338