The Dallas Hereditary Spherocytosis Cohort Study

This study has been terminated.
(Insufficient staff to continue pursuing project)
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01141621
First received: June 4, 2010
Last updated: May 13, 2013
Last verified: May 2013

June 4, 2010
May 13, 2013
May 2010
May 2013   (final data collection date for primary outcome measure)
Health related quality of life [ Time Frame: Approximately at 5 years ] [ Designated as safety issue: No ]
PedsQL measurement
Same as current
Complete list of historical versions of study NCT01141621 on ClinicalTrials.gov Archive Site
  • Primary indications for splenectomy [ Time Frame: Approximately at 5 years ] [ Designated as safety issue: No ]
    Primary indication for splenectomy determined at time of splenectomy, if performed.
  • Complications of HS [ Time Frame: Approximately at 5 years and at 10 years ] [ Designated as safety issue: No ]
  • Complications of splenectomy [ Time Frame: Approximately at 5 years ] [ Designated as safety issue: No ]
  • Diagnosis of HS [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Dallas Hereditary Spherocytosis Cohort Study
The Dallas Hereditary Spherocytosis Cohort Study

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma

Non-Probability Sample

Center for Cancer and Blood Disorders outpatient clinics

Hereditary Spherocytosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
55
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01141621
IRB # 022010-024
No
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Not Provided
University of Texas Southwestern Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP