Terry Robinson
#5901 Primary Ciliary Dyskinesia Study
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this longitudinal study protocol is to define age-related prevalence of phenotypic characteristics and the progression of key features of lung disease in participants with one of these disorders, Primary Ciliary Dyskinesia (PCD). In PCD, the abnormal structure and function of cilia results in impaired clearance of secretions and consequent obstruction and chronic recurrent infection in the airways, sinuses and middle ears. The clinical manifestations include chronic/recurrent bronchitis and pneumonia, chronic/recurrent sinusitis and chronic otitis media. Chronic airway infection ultimately results in structural damage to the airways, known as bronchiectasis, function. Although it seems likely that the onset of PCD airway disease occurs early in childhood, as has been reported for cystic fibrosis (CF), the clinical course of PCD lung disease is not well-defined, nor, is the time course of emergence of specific microbial pathogens, or the age of onset and rate of progression of airway disease and bronchiectasis.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
Phase:
N/AEligibility
Ages Eligible for Study:
5 years to 18 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
# Individuals 5-18 years of age with confirmed diagnosis of PCD (based on criteria in the Protocol)
# Individuals 5-18 years of age with #probable# PCD (based on criteria in the Protocol)
# Informed consent by participant or parent/legal guardian of minor participant.
Key Exclusion Criteria:
# Inability to maintain follow-up appointments
# Post lung transplantation
# Female of childbearing potential who is pregnant or lactating (radiation risk at visits 1,3 and 5; therefore, serum pregnancy test will be performed prior to chest CT at those visits)
# Co-existing severe diseases that may have significant impact on lung function (severe congenital heart disease, severe scoliosis), or respiratory infections (AIDS) or overall health status (cancer, end-stage renal disease)
Additional Study Details
Official Title:
Longitudinal Study of Primary Ciliary Dyskinesia: Participants 5-18 Years of Age (#5901)Anticipated start date:
11/30/2008Lead Sponsor:
NIHCollaborator(s):
- National Ctr for Research Resources
- Office of Rare Disease
Investigator(s):
- Carlos Milla
- Richard B Moss
- Carol K. Conrad
- David N Cornfield
- Paul K Mohabir
- John David Mark
- Terry Earl Robinson
- Lauren J Witcoff
- Dr. Jacquelyn Marie Zirbes DNP
- Zoe Davies RN
- Colleen Dunn RCP
- Martha Hamilton
- Yan Ki Angela Leung
- Daisy Carolina Diaz
Study Type:
ObservationalPurpose:
NOTNEEDEDDuration:
LongitudinalSelection:
Defined PopulationTiming:
ProspectiveTotal Number to be Enrolled:
150Total Number to be Enrolled at Stanford:
20More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
11/11/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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