Newborn Screening for Severe Combined Immunodeficiency (SCID) in a High-Risk Population

Severe Combined Immunodeficiency Clinical Trial

Official title:

Newborn Screening for SCID in a High-Risk Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845416
• Other study ID #: H55235-32562-01
• Secondary ID: R03HD060311
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: July 13, 2012
• Start date: March 2009
• Est. completion date: November 2011

Study information

• Verified date: July 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goal of the proposed research is to establish the validity of a newborn screening method for severe combined immunodeficiency (SCID). The assay to be used is developed on the basis of PCR quantification of T-cell receptor excision circles (TRECs) that is absent in SCID patients, thus correlating with the disease

Description:

To show that early diagnosis of SCID with a TREC screening assay can warrant timely treatment of the disease and avoid life-threatening infections on patients. Babies with SCID are unable to fight infections. They become severely ill in their first months of life and do not survive unless their immune systems can be restored. SCID can be treated by bone marrow transplant if recognized early. The newborn screening test to be employed in this study is designed to diagnose SCID before infections occur. By conducting a pilot testing program in a high-risk population on the Navajo Indian Reservation, where one in 2,000 infants is born with SCID, we hope to confirm the benefits of newborn screening for early diagnosis of SCID

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

Inclusion Criteria:

• Birth in a study hospital on the Navajo Reservation

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Lymphopenia
• Severe Combined Immunodeficiency
• T Cell Lymphocytopenia

Locations

Country	Name	City	State
United States	Chinle Hospital	Chinle	Arizona
United States	Tuba City Hospital	Tuba City	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States,