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The Dallas Hereditary Spherocytosis Cohort Study

This study has been terminated.
(Insufficient staff to continue pursuing project)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01141621
First Posted: June 10, 2010
Last Update Posted: May 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
June 4, 2010
June 10, 2010
May 14, 2013
May 2010
May 2013   (Final data collection date for primary outcome measure)
Health related quality of life [ Time Frame: Approximately at 5 years ]
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 ]
    Primary indication for splenectomy determined at time of splenectomy, if performed.
  • Complications of HS [ Time Frame: Approximately at 5 years and at 10 years ]
  • Complications of splenectomy [ Time Frame: Approximately at 5 years ]
  • Diagnosis of HS [ Time Frame: At enrollment ]
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
Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01141621
IRB # 022010-024
No
Not Provided
Not Provided
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Not Provided
University of Texas Southwestern Medical Center
May 2013