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
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Condition or disease |
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Hereditary Oral Clefts |
Study Type : | Observational |
Actual Enrollment : | 690 participants |
Observational Model: | Family-Based |
Time Perspective: | Prospective |
Official Title: | Genetic Analysis of Hereditary Non-Syndromic Oral Clefts |
Actual Study Start Date : | August 31, 1997 |
Actual Primary Completion Date : | March 12, 2020 |
Actual Study Completion Date : | March 12, 2020 |

Group/Cohort |
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Control
healthy individuals with no history of oral cleftsto serve as controls
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Oral Cleft Family Members
individuals with unilateral or bilateral cleft lip with or without cleft palate and their unaffected relatives
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- 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
- 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:
- A cluster of 2 or more affected first degree relatives, such as a parent and two offspring or 2 siblings, or
- The occurrence of oral clefts in each of 2 generations in either the proband's paternal or maternal lineages.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00340626
Syrian Arab Republic | |
IBN Al Nafees Hospital | |
Damascus, Syrian Arab Republic |
Principal Investigator: | Joan Bailey-Wilson, Ph.D. | National Human Genome Research Institute (NHGRI) |
Responsible Party: | National Human Genome Research Institute (NHGRI) |
ClinicalTrials.gov Identifier: | NCT00340626 |
Other Study ID Numbers: |
999997035 OH97-HG-N035 |
First Posted: | June 21, 2006 Key Record Dates |
Last Update Posted: | March 13, 2020 |
Last Verified: | March 2020 |
Linkage Analysis Genotyping Birth Defects Family Study Positional Cloning |