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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845416
First Posted: February 18, 2009
Last Update Posted: July 16, 2012
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 California, San Francisco
  Purpose
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

Condition
Severe Combined Immunodeficiency T Cell Lymphocytopenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Newborn Screening for SCID in a High-Risk Population

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Enrollment: 1800
Study Start Date: March 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Navajo Indians
Criteria

Inclusion Criteria:

  • Birth in a study hospital on the Navajo Reservation

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845416


Locations
United States, Arizona
Chinle Hospital
Chinle, Arizona, United States
Tuba City Hospital
Tuba City, Arizona, United States
Sponsors and Collaborators
University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00845416     History of Changes
Other Study ID Numbers: H55235-32562-01
R03HD060311 ( U.S. NIH Grant/Contract )
First Submitted: February 17, 2009
First Posted: February 18, 2009
Last Update Posted: July 16, 2012
Last Verified: July 2012

Keywords provided by University of California, San Francisco:
TREC
T cell
Primary Immunodeficiency
PID
Navajo
SCID

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Severe Combined Immunodeficiency
Lymphopenia
Immune System Diseases
Infant, Newborn, Diseases
DNA Repair-Deficiency Disorders
Metabolic Diseases
Leukopenia
Leukocyte Disorders
Hematologic Diseases