- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00845416
Newborn Screening for Severe Combined Immunodeficiency (SCID) in a High-Risk Population
July 13, 2012 updated by: University of California, San Francisco
Newborn Screening for SCID in a High-Risk Population
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
Study Overview
Status
Completed
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
Enrollment (Actual)
1800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Chinle, Arizona, United States
- Chinle Hospital
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Tuba City, Arizona, United States
- Tuba City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Navajo Indians
Description
Inclusion Criteria:
- Birth in a study hospital on the Navajo Reservation
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
February 17, 2009
First Submitted That Met QC Criteria
February 17, 2009
First Posted (Estimate)
February 18, 2009
Study Record Updates
Last Update Posted (Estimate)
July 16, 2012
Last Update Submitted That Met QC Criteria
July 13, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H55235-32562-01
- R03HD060311 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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Great Ormond Street Hospital for Children NHS Foundation...RecruitingSevere Combined Immunodeficiency, X-LinkedUnited Kingdom
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National Institute of Allergy and Infectious Diseases...UnknownX-Linked Combined Immunodeficiency DiseasesUnited States
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National Institute of Allergy and Infectious Diseases...CompletedSevere Combined ImmunodeficiencyUnited States