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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00006855 |
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Date of registration:
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15/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Identifikation and Evaluation of different gene loci for nsCL/P and nsCPO in a Vietnamese population
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Scientific title:
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Identifikation and Evaluation of different gene loci for nsCL/P and nsCPO in a Vietnamese population |
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Date of first enrolment:
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09/11/2015 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00006855 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science
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Phase:
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Alina
Hinrichs |
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Address:
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Kerpener Straße 36
50931
Köln
Germany |
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Telephone:
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00492214784741 |
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Email:
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alina.hinrichs@uk-koeln.de |
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Affiliation:
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Uniklinik Köln |
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Name:
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Alina
Hinrichs |
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Address:
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Kerpener Straße 31
50731
Köln
Germany |
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Telephone:
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0221 478 4741 |
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Email:
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alina.hinrichs@uk-koeln.de |
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Affiliation:
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Uniklinik Köln Poliklinik für Kieferorthopädie |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients, with nsCL/P or nsCPO
Patients, whose four grandparents are of Vietnamese descent.
written consent to participate in the study.
ASA-group 1-3.
Inclusion criteria control patients:
Patients, without a syndrome
Patients, whose four grandparents are of Vietnamese decent.
written consent to participate in the study.
ASA-group 1-3.
Exclusion criteria: Exclusion criteria patient:
no written consent to participate in the study.
patients with a syndrome
ASA-group 4-8.
Exclusion criteria control:
Patients, with a CL/P or CPO or
signs of a CL/P or CPO
Relatives of a cleft patient
no written consent to participate in the study.
patients with a syndrome
ASA-group 4-8.
Age minimum:
None
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Q37.4
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Cleft hard and soft palate with unilateral cleft lip
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Cleft hard palate with bilateral cleft lip
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Unspecified cleft palate with unilateral cleft lip
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Cleft hard and soft palate with bilateral cleft lip
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Q37.0
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Cleft hard palate
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Cleft soft palate with unilateral cleft lip
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Cleft hard palate with unilateral cleft lip
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Cleft soft palate with bilateral cleft lip
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Q37.3
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Q37.9
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Q37.0
Q37.1
Q37.2
Q37.3
Q37.4
Q37.5
Q37.8
Q37.9
Q35.1
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Q37.2
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Q37.5
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Q37.8
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Q35.1
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Q37.1
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Unspecified cleft palate with bilateral cleft lip
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Intervention(s)
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Group 1: Peripheral venous blood samples (5-10ml EDTA blood) or saliva samples (2ml) are obtained from cases for DNA-extraction.
DNA extraction and genotyping are performed at the Department of Genomics Bonn, Germany.
Patient’s details include sex, date of birth and Relations to other study memebers as well as phenotype of clefting (LAHSHAL-classification)
In addition, a detailed questionnaire is completed to identify possible prenatal contributory factors (maternal illnesses during pregnancy, maternal ingestion of known teratogenic medications or toxins). Patients´ details are collected in a data base.
Pictures and eventually impressions of the upper and lower jaw are taken.
Group 2: Peripheral venous blood samples (5ml EDTA-blood) or saliva samples (2ml) are obtained from controls for DNA-extraction.
DNA extraction and genotyping are performed at the Department of Genomics Bonn, Germany.
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Primary Outcome(s)
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The primary end point of the study is to verify the identified genetic loci respectively identify further genetic loci or genes causative for non-syndromic cleft lip and palate (nsCLP) or cleft palate only (nsCPO) in a Vietnamese population.
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Secondary Outcome(s)
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Evaluation of phenotyp-genotyp correlation
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Source(s) of Monetary Support
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Geschäftsstelle der DGKFOUniversitätsklinikum GießenPoliklinik für Kieferorthopädie
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Ethics review
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Status: Approved
Approval date: 29/01/2015
Contact:
gs-ek@uni-koeln.de
Ethikkommission der Medizinischen Fakultät der Universität zu Köln
+49-221-478 82900
gs-ek@uni-koeln.de
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