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Immunologic Evaluation in Patients With DiGeorge Syndrome or Velocardiofacial Syndrome

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ClinicalTrials.gov Identifier: NCT00005102
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : April 7, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by:
National Center for Research Resources (NCRR)

Tracking Information
First Submitted Date April 6, 2000
First Posted Date April 7, 2000
Last Update Posted Date June 24, 2005
Study Start Date January 1995
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immunologic Evaluation in Patients With DiGeorge Syndrome or Velocardiofacial Syndrome
Official Title Immunologic Evaluation in Patients With DiGeorge Syndrome or Velocardiofacial Syndrome
Brief Summary

OBJECTIVES:

I. Determine the pattern of immunologic reconstitution in patients with T-cell compromise due to DiGeorge syndrome or velocardiofacial syndrome.

II. Determine any correlation between immunologic function in these patients and chromosome 22 deletion breakpoints.

III. Determine presence of sustained immunologic compromise in older patients.

Detailed Description

PROTOCOL OUTLINE:

Blood samples are collected at diagnosis of chromosome 22q11 deletion and assessed for lymphocyte proliferation in response to mitogens phytohemagglutinin, pokeweed mitogen, and concanavalin A (mitogen stimulation analyses). These analyses are repeated at 4 months along with a quantitative analysis of immunoglobulin.

At 8 months, patients are tested for their lymphocytes' ability to respond to antigens (candida, tetanus, and diphtheria). At 1 year, patients have lymphocyte subset, IgG, IgA, and IgM analyses performed. Quantitative evaluations of antibody titers to diphtheria, tetanus, Haemophilus influenza, and hepatitis B are also performed.

Over 1 year of age, all studies are performed if the patient is seen for a single visit.

Study Type Observational
Study Design Observational Model: Natural History
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • DiGeorge Syndrome
  • Shprintzen Syndrome
  • Chromosome Abnormalities
  • Abnormalities, Multiple
  • Conotruncal Cardiac Defects
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: June¬†23,¬†2005)
11
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • Conotruncal cardiac lesion to be repaired by surgery AND Chromosome 22q11 deletion by FISH
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00005102
Other Study ID Numbers NCRR-M01RR00240-1571
CHP-IRB-95-903
CHP-GCRC-1571
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Center for Research Resources (NCRR)
Collaborators Children's Hospital of Philadelphia
Investigators
Study Chair: Kathleen E. Sullivan Children's Hospital of Philadelphia
PRS Account National Center for Research Resources (NCRR)
Verification Date December 2003