NCT01141621

Brief Summary

The purpose of this study is to

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

3 years

First QC Date

June 4, 2010

Last Update Submit

May 13, 2013

Conditions

Hereditary Spherocytosis

Keywords

HScongenital hemolytic anemiasplenectomyquality of life

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life

    PedsQL measurement

    Approximately at 5 years

Secondary Outcomes (4)

  • Primary indications for splenectomy

    Approximately at 5 years

  • Complications of HS

    Approximately at 5 years and at 10 years

  • Complications of splenectomy

    Approximately at 5 years

  • Diagnosis of HS

    At enrollment

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Center for Cancer and Blood Disorders outpatient clinics

You may qualify if:

  • Diagnosis of HS with or without prior splenectomy
  • Age 0 - 21 years
  • Spanish-speaking subjects are eligible to participate

You may not qualify if:

  • Unable to provide contact information for follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Spherocytosis, HereditaryAnemia, Hemolytic, Congenital

Condition Hierarchy (Ancestors)

Anemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 10, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 14, 2013

Record last verified: 2013-05