The Dallas Hereditary Spherocytosis Cohort Study

Hereditary Spherocytosis Clinical Trial

Official title:

The Dallas Hereditary Spherocytosis Cohort Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01141621
• Other study ID #: IRB # 022010-024
• Status: Terminated
• Phase: N/A
• First received: June 4, 2010
• Last updated: May 13, 2013
• Start date: May 2010
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to

1. better characterize the short term and long term natural history of hereditary spherocytosis (HS) including diagnosis, complications, and indications for and response to splenectomy

2. evaluate and describe the health-related quality of life in children with HS.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hereditary Spherocytosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life	PedsQL measurement	Approximately at 5 years	No
Secondary	Primary indications for splenectomy	Primary indication for splenectomy determined at time of splenectomy, if performed.	Approximately at 5 years	No
Secondary	Complications of HS		Approximately at 5 years and at 10 years	No
Secondary	Complications of splenectomy		Approximately at 5 years	No
Secondary	Diagnosis of HS		At enrollment	No