FaceBase Biorepository

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01252264
First received: November 30, 2010
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

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
Craniofacial Abnormalities
Cleft Lip
Cleft Palate

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: FaceBase Biorepository

Resource links provided by NLM:


Further study details as provided by University of Iowa:

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.

Estimated Enrollment: 5000
Study Start Date: November 2010
Groups/Cohorts
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals with a craniofacial anomaly and their family members.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252264

Contacts
Contact: Jenni Rigdon, MSN-CNL, RN 319-335-6741 jennifer-rigdon@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Jeff Murray, MD         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Jeff Murray, MD University of Iowa
  More Information

Publications:
Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01252264     History of Changes
Other Study ID Numbers: NIDCR #: 10-183-E, U01DE020057
Study First Received: November 30, 2010
Last Updated: November 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
biorepository
genetics
craniofacial
cleft lip
cleft palate

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

ClinicalTrials.gov processed this record on September 18, 2014