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
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Tracking Information | ||||
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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. |
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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. |
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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 |
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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. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Enrollment |
11 | |||
Original Enrollment | Same as current | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria |
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Sex/Gender |
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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 |
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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 |
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PRS Account | National Center for Research Resources (NCRR) | |||
Verification Date | December 2003 |