Suspended

Lymphocyte Response and Immunoglobulin Analysis in DiGeorge and Velocardiofacial Syndromes

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What is being collected

Data Collection

Who is being recruted

Congenital Abnormalities+23

+ Cardiovascular Diseases

+ Endocrine System Diseases

See all eligibility criteria
How is the trial designed

Natural History

Observing the progression of a disease in untreated individuals in order to understand its typical course and outcomes.
Observational
Study Start: January 1995
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Study ContactKathleen E. Sullivan
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00005102
Principal SponsorNational Center for Research Resources (NCRR)
Study ContactKathleen E. Sullivan
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Natural History

These studies observe how a disease progresses over time without active treatment. They help researchers understand how conditions typically develop, change, and impact quality of life.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesCardiovascular DiseasesEndocrine System DiseasesHeart Defects, CongenitalHeart DiseasesHemic and Lymphatic DiseasesHypoparathyroidismLymphatic DiseasesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesParathyroid DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiovascular AbnormalitiesCraniofacial AbnormalitiesDisease AttributesChromosome DisordersLymphatic Abnormalities22q11 Deletion SyndromeAbnormalities, MultipleChromosome AberrationsDiGeorge SyndromeRespiratory Tract DiseasesGenetic Diseases, InbornRare Diseases

Criteria

Conotruncal cardiac lesion to be repaired by surgery AND Chromosome 22q11 deletion by FISH

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Children's Hospital of Philadelphia

Philadelphia, United StatesOpen Children's Hospital of Philadelphia in Google Maps
SuspendedOne Study Center