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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
History of Changes
  Purpose

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.

Condition
Hereditary Spherocytosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Dallas Hereditary Spherocytosis Cohort Study

Resource links provided by NLM:

MedlinePlus related topics: Anemia
U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Health related quality of life [ Time Frame: Approximately at 5 years ] [ Designated as safety issue: No ]
    PedsQL measurement


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 55
Study Start Date: May 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Center for Cancer and Blood Disorders outpatient clinics

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01141621     History of Changes
Other Study ID Numbers: IRB # 022010-024
Study First Received: June 4, 2010
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
HS
congenital hemolytic anemia
splenectomy
quality of life

Additional relevant MeSH terms:
Spherocytosis, Hereditary
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 23, 2013