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Registration and sample collection for identification of genetic and public health characteristics of the major birth defects in korea

Status Approved

First Submitted Date

2013/11/18
Registered Date

2019/03/26
Last Updated Date

2013/11/18

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003671
Unique Protocol ID	2010-0260
Public/Brief Title	Registration and sample collection for identification of genetic and public health characteristics of the major birth defects in korea
Scientific Title	Registration and sample collection for identification of genetic and public health characteristics of the major birth defects in korea
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2010-0260
Approval Date	2010-05-19
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Hye-sung Won
Title	professor
Telephone	+82-2-3010-3644
Affiliation	Asan Medical Center
Address
Contact Person for Public Queries
Name	Hye-sung Won
Title	professor
Telephone	+82-2-3010-3644
Affiliation	Asan Medical Center
Address
Contact Person for Updating Information
Name	Seong-ran Lim
Title	researcher
Telephone	+82-43-719-8675
Affiliation	Korea Centers for Disease Control and Prevention
Address

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 6
Overall Recruitment Status	Completed
Date of First Enrollment	2010-05-25 Actual
Target Number of Participant	1400
Primary Completion Date	2012-12-24 , Actual
Study Completion Date	2013-01-03 , Actual
Name of Study	Ajou University Hospital
Recruitment Status	Completed
Date of First Enrollment	2010-11-30 ,
Recruitment Status by Participating Study Site 2
Name of Study	Ewha Womans University Medical Center
Recruitment Status	Completed
Date of First Enrollment	2011-01-02 ,
Recruitment Status by Participating Study Site 3
Name of Study	Cheil General Hospital and Women's Healthcare Center
Recruitment Status	Completed
Date of First Enrollment	2010-12-06 ,
Recruitment Status by Participating Study Site 4
Name of Study	The Catholic University of Korea, Yeouido St. Mary's Hospital
Recruitment Status	Completed
Date of First Enrollment	2010-11-30 ,
Recruitment Status by Participating Study Site 5
Name of Study	Yonsei University Health System, Severance Hospital
Recruitment Status	Completed
Date of First Enrollment	2010-11-30 ,
Recruitment Status by Participating Study Site 6
Name of Study	Asan Medical Center
Recruitment Status	Completed
Date of First Enrollment	2010-05-25 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Korea Centers for Disease Control and Prevention
Organization Type	Government
Project ID	2010E6300800

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea Centers for Disease Control and Prevention
Organization Type	Government

7. Study Summary

Study Summary Information
Lay Summary	The purpose of this registry is to investigate genetic and health characteristics of pregnant women diagnosed with/without congenital abnormalies in fetus through conducting survey and collecting specimens in domestic six hospitals specializing in congentical abnormalies in fetus (Seoul Asan Medical Center, Ajou University Hospital, Ewha Womans University Mokdong Hospital, Cheil General Hospital & Womans Healthcare Center, The Catholic University of Korea Yeouido St. Mary's Hospital, Yonsei Severance Hospital).

Study Summary Information

Lay Summary

The purpose of this registry is to investigate genetic and health characteristics of pregnant women diagnosed with/without congenital abnormalies in fetus through conducting survey and collecting specimens in domestic six hospitals specializing in congentical abnormalies in fetus (Seoul Asan Medical Center, Ajou University Hospital, Ewha Womans University Mokdong Hospital, Cheil General Hospital & Womans Healthcare Center, The Catholic University of Korea Yeouido St. Mary's Hospital, Yonsei Severance Hospital).

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-control
Time Perspective	Prospective
Target Number of Participant	1400
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label Case
Cohort/ Group 1	Cohort/Group Description - Collection of clinical data and specimen from pregnant woman who is diagnosed with congenital abnormalies of her fetus detected by ultrasonography in the middle stage of her pregnancy and from her fetus and husband
Cohort/ Group 2	Cohort/Group Label Control
Cohort/ Group 2	Cohort/Group Description - Collection of clinical data and specimen from pregnant woman who is not diagnosed with congenital abnormalies of her fetus detected by ultrasonography in the middle stage of her pregnancy and from her fetus and husband
Biospecimen Collection & Archiving	: DNA Collect & Archive: Sample with DNA
Biospecimen Description	DNA, Plasma, Urine, Placenta

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	- Pregnant woman who visits 6 study centers and is diagnosed with/without congenital abnormalies of her fefus detected by ultrasonography during her pre delivery inspection and her fetus and husband
Sampling Method	nonprobability sampling
Condition(s)/Problem(s)	* (Q00-Q99)Congenital malformations, deformations and chromosomal abnormalities (Q89.8)Other specified congenital malformations
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description <Case group> Pregnant woman who visits the site for prenatal examination and is diagnosed with congenital abnormalies in fetus and her fetus and husband <Control group> -Pregnant woman who visits the site for prenatal examination and is not diagnosed with congenital abnormalies in fetus detected by ultrasonography -1:1 matching with pregnant women in case group based on their age, their pregnancy week number and gender of their fetus
Exclusion Criteria	- History of childbirth with chromosomal abnormalities - Parents with balanced translocation carrier - History of structural birth defects - Birth abnormalies under prenatal ultrasonography - Abnormalies in umbilical cord or placenta under prenatal ultrasonography - History of administration of FDA preganacy Category D drug during pregnancy - History of illegal drug use - Maternal diseases potentially associated with fetal defects - Birth defects discovered after delivery - Family history of genetic diseases - Pregnant women who are exposed to clinically harmful environment - Low birth weight or high birth weight infant - Pregnant women with abnormal BMI
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Relationship between environmental pollution and occurrence of congenital abnormalies
Timepoint	At the completion of study
Secondary Outcome(s) 1
Outcome	Risk factors associated with congenital abnormalies
Timepoint	At the completion of study

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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