RecruitingNCT00227253

Chromosome 18 Clinical Research Center

The Chromosome 18 Clinical Research Center


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

4,000 participants

Start Date

Sep 1, 1993

Study Type

OBSERVATIONAL

Conditions

Summary

Our vision, that of the researchers at the University of Texas Health Science Center at San Antonio, is that every person with a chromosome 18 abnormality will have an autonomous and healthy life. Our mission is to provide families affected by chromosome 18 abnormalities with comprehensive medical and educational information. Our goals are to provide definitive medical and education resources for the families of individuals with chromosome 18 abnormalities; perform and facilitate groundbreaking clinical and basic research relating to the syndromes of chromosome 18; and to provide treatments to help these individuals overcome the effects of their chromosome abnormality.


Eligibility

Inclusion Criteria3

  • Must have a confirmed diagnosis of Chromosome 18 or be the parent/guardian of a child with Chromosome 18
  • Subject must be at least one year of age to participate in the clinical examination aspect of the study (due to issues of venous access and blood volume required to complete studies)
  • General health status: good

Exclusion Criteria4

  • Pregnant women
  • Dead fetuses
  • Prisoners
  • Non-viable neonates or neonates of uncertain viability

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREDetermination of growth hormone status

Growth hormone stimulating testing using Arginine and Clonidine, Corticotrophin releasing hormone stimulation test

PROCEDUREMeasurement of growth, thyroid and sex hormone levels

Gonadotrophin releasing hormone stimulation test Thyroid testing - T4, TSH, T3 uptake, and anti-thyroidal antibodies baseline sample - no medication administered

PROCEDUREBehavior and neuropsychometric evaluations

evaluation by neuropsychologist, standardized testing geared to study participant's age, abilities and past medical history

PROCEDUREAudiological and ear, nose and throat examination

neurotological exam, behavioral audiometry, immittance audiometry, assessment of the function of the inner ear using otoacoustic emissions, Auditory brain responses

PROCEDUREMagnetic resonance imaging of the brain

MRI of the brain - standard clinical procedure

PROCEDUREDysmorphology evaluation

Genetic evaluation with picture and measurements, physical exam

PROCEDURENeurology examination

physical examination including observation of balance, coordination and reflexes.

PROCEDUREDental evaluation

Visual detal inspection with panorex X-ray of the entire mouth

PROCEDURESpeech pathology evaluation

Standardized speech \& language tests and naturalistic assessment procedures.

PROCEDUREPsychiatric evaluation

Psychiatric interview about history of psychiatric and medical illnesses, family psychiatric and medical history, demographic info also obtained

PROCEDUREOrthopedic evaluation

Physical exam by orthopedic surgeon and a dysplasia series of radiographs including AP and lateral radiographics of the feet, APs of the knees, pelvis, thoracic lumbar spine and chest, laterals of thoracic lumbar and cervical spine, lateral of the skull, AP and lateral of the forearm, bone age evaluation with radiograph of left hand

PROCEDUREOphthalmologic evaluation

exam will determine visual acuity using one of the following: Snellen chart, Allen acuity, target acuity, optokinetic nystagmus (OKN), or Teller acuity depending on study participants ability level. Motility/alignment will also be determined using cover/uncover test. Pupils examined using slit lamp. Dilated fundus exam and cycloplegic refraction which will require dilating drops in both eyes. Cyclogen 1% and NeuSynephrine 2.5% are using. In children less than 6 months old, less potent mydriatrics and cycloplegics are used Cyclogel 0.5% or Tropicamide 1%. Intraocular pressure will be measured in adults and cooperative teens using applanation tonometry. A topical anesthetic will be used to perform this measurement.

PROCEDUREGastrointestinal evaluation

physical exam and medical history by board certified gastroenterologist.


Locations(2)

University Health Systems Hospital

San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT00227253


Related Trials