Genetics of Spina Bifida and Anencephaly | NCT00636233

Studies
Genetics of Spina Bifida and Anencephaly

NCT00636233

Sponsor

Duke University

Status

Completed

Last Update Posted

Apr 2, 2020Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Anencephaly
Acrania

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01NS039818	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1993

Primary Completion Date

Aug 2, 2017Actual

Completion Date

Aug 2, 2017Actual

First Submitted Date

Mar 9, 2008

First Submission Date that Met QC Criteria

Mar 9, 2008

First Posted Date

Mar 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2020

Last Update Posted Date

Apr 2, 2020Actual

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this research study is to discover the genetic and environmental factors that contribute to the cause of neural tube defects such as spina bifida and anencephaly. Ultimately, this type of research may result in improved diagnosis, improved treatment and possibly prevention.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10,000Estimated

Label	Type	Description	Intervention Names
Anencephaly		Fetuses with anencephaly, parents and siblings

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
genetic factors associated with neural tube defects	This study aims to discover genetic factors associated with neural tube defects such as anencephaly.	end of the study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Not currently enrolling new participants.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Any current pregnancy affected by anencephaly or acrania.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allison Ashley-Koch, PhD	Duke Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27710	United States

References Module

Citations

Not provided

ID	Term
D000757	Anencephaly
D009436	Neural Tube Defects

ID	Term
D009421	Nervous System Malformations
D009422	Nervous System Diseases
D009008	Abnormalities, Severe Teratoid
D000013	Congenital Abnormalities

Label	URL
Anencephaly study description	View source
Neural tube defect study description	View source