Trial record 2 of 44 for:    eye diseases AND university of iowa

FaceBase Biorepository

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01252264
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : May 4, 2018
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Jeff Murray, University of Iowa

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.

Condition or disease
Craniofacial Abnormalities Cleft Lip Cleft Palate

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 Type : Observational
Actual Enrollment : 5000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: FaceBase Biorepository
Actual Study Start Date : November 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Individuals with craniofacial anomalies
Individuals who have a craniofacial anomaly (head, face, or eye disorder)
Control Subjects
Family members of individuals with a craniofacial anomaly

Biospecimen Retention:   Samples With DNA
  • A biological sample will be obtained by a blood draw. In adults, we will obtain a blood sample of 1-2 tablespoons (10-30 mL). For children, the amount will be smaller depending on their weight: 1 mL per kg to a maximum of 30 mL.
  • If a blood draw is refused, DNA can be taken from a cheek swab, spit sample or fingerstick.
  • If a participant is having surgery for a medical reason, we may request a tissue sample (for example: skin, bone, or muscle). If there were to be extra tissue, amniotic fluid, other biological samples available from a procedure performed for clinical indications, we may request a sample.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 125 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals with a craniofacial anomaly and their family members.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01252264

United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Jeff Murray
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Jeff Murray, MD University of Iowa

Responsible Party: Jeff Murray, Principal Investigator, University of Iowa Identifier: NCT01252264     History of Changes
Other Study ID Numbers: 200912764
U01DE020057 ( U.S. NIH Grant/Contract )
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeff Murray, University of Iowa:
cleft lip
cleft palate

Additional relevant MeSH terms:
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Jaw Diseases
Musculoskeletal Diseases
Cleft Lip
Cleft Palate
Craniofacial Abnormalities
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Jaw Abnormalities
Maxillofacial Abnormalities
Musculoskeletal Abnormalities