NCT00845416

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

July 16, 2012

Status Verified

July 1, 2012

Enrollment Period

2.7 years

First QC Date

February 17, 2009

Last Update Submit

July 13, 2012

Conditions

Severe Combined ImmunodeficiencyT Cell Lymphocytopenia

Keywords

TRECT cellPrimary ImmunodeficiencyPIDNavajoSCID

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Navajo Indians

You may qualify if:

  • Birth in a study hospital on the Navajo Reservation

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chinle Hospital

Chinle, Arizona, United States

Location

Tuba City Hospital

Tuba City, Arizona, United States

Location

MeSH Terms

Conditions

Severe Combined ImmunodeficiencyPrimary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

March 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

July 16, 2012

Record last verified: 2012-07

Locations

US(2)