Genetics of Spina Bifida and Anencephaly

March 31, 2020 updated by: Duke University

The Hereditary Basis of Neural Tube Defects

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Any current pregnancy affected by anencephaly or acrania.

Description

Not currently enrolling new participants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Anencephaly
Fetuses with anencephaly, parents and siblings

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Allison Ashley-Koch, PhD, Duke Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1993

Primary Completion (ACTUAL)

August 2, 2017

Study Completion (ACTUAL)

August 2, 2017

Study Registration Dates

First Submitted

March 9, 2008

First Submitted That Met QC Criteria

March 9, 2008

First Posted (ESTIMATE)

March 14, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00016517
  • R01NS039818 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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