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Genetic Analysis of Hereditary Non-Syndromic Oral Clefts

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ClinicalTrials.gov Identifier: NCT00340626
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

Tracking Information
First Submitted Date June 19, 2006
First Posted Date June 21, 2006
Last Update Posted Date March 13, 2020
Actual Study Start Date August 31, 1997
Actual Primary Completion Date March 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2019)
Identification of genetic risk variants for oral clefts [ Time Frame: Ongoing ]
To identify and characterize genes responsible for non- syndromic and syndromic oral clefts by genetic family studies including linkage analysis, association analysis, positional cloning, evaluation of candidate genes, and eventual evaluation of mutations in identified genes.
Original Primary Outcome Measures Not Provided
Change History
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 Genetic Analysis of Hereditary Non-Syndromic Oral Clefts
Official Title Genetic Analysis of Hereditary Non-Syndromic Oral Clefts
Brief Summary In a collaborative effort with the IBN AL-NAFEES Hospital (Damascus, Syrian Arab Republic), individuals from multiplex families determined to have hereditary oral clefts will be studied. The purpose of this study is to identify the gene(s) involved in heritable oral clefts by linkage analysis and gene mapping strategies. Characterization of genes involved in inherited oral clefts could provide important insight into the inheritance and pathogenesis of this disease.
Detailed Description In a collaborative effort with the IBN AL-NAFEES Hospital (Damascus, Syrian Arab Republic), individuals from multiplex families determined to have hereditary oral clefts will be studied. Healthy Syrian individuals with no family history of oral clefts will also be enrolled as a comparison group. The purpose of this study is to identify the gene(s) involved in heritable oral clefts by linkage analysis and gene mapping strategies. Characterization of genes involved in inherited oral clefts could provide important insight into the inheritance and pathogenesis of this disease. All families are enrolled into the study by our Syrian collaborators (under Ethics Board approval from the IBN AL-NAFEES Hospital) and only coded phenotype data and coded biospecimens are ever received at the NIH.
Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, saliva
Sampling Method Non-Probability Sample
Study Population individuals with unilateral or bilateral cleft lip with or without cleft palate and their unaffected relatives@@@
Condition Hereditary Oral Clefts
Intervention Not Provided
Study Groups/Cohorts
  • Control
    healthy individuals with no history of oral cleftsto serve as controls
  • Oral Cleft Family Members
    individuals with unilateral or bilateral cleft lip with or without cleft palate and their unaffected relatives
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 12, 2020)
690
Original Enrollment
 (submitted: June 19, 2006)
1000
Actual Study Completion Date March 12, 2020
Actual Primary Completion Date March 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:

Enrollment in this study will be limited to individuals with non-syndromic unilateral or bilateral cleft lip with or without cleft palate and their unaffected relatives, from families which meet the following criteria:

  1. A cluster of 2 or more affected first degree relatives, such as a parent and two offspring or 2 siblings, or
  2. The occurrence of oral clefts in each of 2 generations in either the proband's paternal or maternal lineages.
  3. The occurrence of oral clefts in 2 or more cousins (up to second cousins)

The subject population is comprised of probands and their families previously examined at the IBN-AL NAFEES Hospital or at other hospitals and clinics in the Syrian Arab Republic as well

as healthy controls from the same population. Consent documents are in Arabic language for non-English-speaking subjects

EXCLUSION CRITERIA:

Individuals unable to provide consent, except for cases who are children and mentally impaired persons with consenting parents or guardians.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Syrian Arab Republic
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00340626
Other Study ID Numbers 999997035
OH97-HG-N035
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
Study Sponsor National Human Genome Research Institute (NHGRI)
Collaborators Not Provided
Investigators
Principal Investigator: Joan Bailey-Wilson, Ph.D. National Human Genome Research Institute (NHGRI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 2020