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

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Brief Title

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

Official Title

Newborn Screening for SCID in a High-Risk Population

Brief 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
    

Detailed 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
    


Study Type

Observational




Condition

Severe Combined Immunodeficiency



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1800

Start Date

March 2009

Completion Date

November 2011

Primary Completion Date

November 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Birth in a study hospital on the Navajo Reservation

        Exclusion Criteria:

          -  None
      

Gender

All

Ages

N/A - 30 Days

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00845416

Organization ID

H55235-32562-01

Secondary IDs

R03HD060311

Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco


Study Sponsor

, , 


Verification Date

July 2012