NCT00636233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 1993

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1993

Completed
14.9 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2017

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2019

Enrollment Period

24.3 years

First QC Date

March 9, 2008

Last Update Submit

March 31, 2020

Conditions

AnencephalyAcrania

Keywords

anencephalyacrania

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Anencephaly

Fetuses with anencephaly, parents and siblings

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any current pregnancy affected by anencephaly or acrania.

Not currently enrolling new participants.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, saliva, cord blood, fetal tissue, cultured fetal cells

MeSH Terms

Conditions

AnencephalyNeural Tube Defects

Condition Hierarchy (Ancestors)

Nervous System MalformationsNervous System DiseasesAbnormalities, Severe TeratoidCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Allison Ashley-Koch, PhD

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2008

First Posted

March 14, 2008

Study Start

May 1, 1993

Primary Completion

August 2, 2017

Study Completion

August 2, 2017

Last Updated

April 2, 2020

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)