- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01141621
The Dallas Hereditary Spherocytosis Cohort Study
The purpose of this study is to
- better characterize the short term and long term natural history of hereditary spherocytosis (HS) including diagnosis, complications, and indications for and response to splenectomy
- evaluate and describe the health-related quality of life in children with HS.
Study Overview
Status
Conditions
Detailed Description
Patients with a new or established diagnosis of HS seen at Children's Medical Center will be asked to enroll in the study. Previous and current medical records will be reviewed to systematically catalogue their history of HS, including diagnosis, complications, hospitalizations, medications and laboratory data. Health-related quality of life questionnaires will be given to the patients and their parents at enrollment and periodically during the follow-up. Those who agree will have up to three small samples of blood collected and frozen for future laboratory studies of complications associated with HS and/or splenectomy.
We anticipate enrolling approximately 200 children and young adults with HS in this study and following them until adulthood (age 18-21 years).
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of HS with or without prior splenectomy
- Age 0 - 21 years
- Spanish-speaking subjects are eligible to participate
Exclusion Criteria:
- Unable to provide contact information for follow-up
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life
Time Frame: Approximately at 5 years
|
PedsQL measurement
|
Approximately at 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary indications for splenectomy
Time Frame: Approximately at 5 years
|
Primary indication for splenectomy determined at time of splenectomy, if performed.
|
Approximately at 5 years
|
Complications of HS
Time Frame: Approximately at 5 years and at 10 years
|
Approximately at 5 years and at 10 years
|
|
Complications of splenectomy
Time Frame: Approximately at 5 years
|
Approximately at 5 years
|
|
Diagnosis of HS
Time Frame: At enrollment
|
At enrollment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB # 022010-024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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