FaceBase Biorepository

Completed

• Conditions: Cleft Palate; Craniofacial Abnormalities; Cleft Lip

• Registration Number: NCT01252264
• Lead Sponsor: Jeff Murray

Brief Summary

The purpose of this study is to find out if there are any genetic differences between people with and without disorders of the head, face, and eye. We will create a biorepository of samples from people with and without these types of birth defects. A biorepository is a collection or "bank" of human tissue materials (such as blood or saliva) for research purposes. These samples will then be available to investigators studying these disorders.

Detailed Description

Samples from the FaceBase Biorepository and data collected from these samples will be available to investigators who are studying birth defects of the head, face, and eye. Data and samples will be deidentified prior to use by other investigators. Researchers will be allowed to use samples and medical information only after approval by the FaceBase Biorepository Data Access Committee. Once the FaceBase Biorepository Data Access Committee has established that the proposed use of the samples and clinical data meet the criteria for sound, ethical research, then the investigator will be granted permission to use a small portion of the sample and have access to clinical data stored in the computer database. Investigators who are not part of the FaceBase Biorepository Research Team will not know participant's names or other personally identifiable information.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-11-30
• Study First Posted: 2010-12-02
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• English speaking
• Individual with a craniofacial anomaly or family member of an individual with a craniofacial anomaly

Exclusion Criteria

• Non-English speaking
• Prisoners
• Minors in foster care or wards of the court

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States