RECRUITING

Natural History of Craniofacial Anomalies and Developmental Growth Variants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: Some head and facial abnormalities are rare and present at birth. Others are more common, and may not show up until puberty. These conditions have different causes and characteristics. Researchers want to learn more about these conditions by comparing people with face, head, and neck abnormalities to family members and to healthy volunteers without such conditions. Objectives: To learn more about abnormal development of the face, head, and neck. To determine their genetic variants. Eligibility: People who have not had surgery for facial trauma: People ages 2 and older with craniofacial abnormalities (may participate offsite) Unaffected relatives ages 2 and older Healthy volunteers ages 6 and older Design: Participants will be screened with medical history and physical exam focusing on head, face, and neck Participants may be followed for several years. Visits may require staying near the clinic for a few days. A visit is required for the following developmental stages, along with follow-up visits: Age 2-6 Age 6-10 Age 11-17 Age 18 and older Visits may include: Medical history Physical exam Questionnaires Oral exam Blood and urine tests Cheek swab: a cotton swab will be wiped across the inside of the cheek several times. Cone beam CT scan (CBCT): x-rays create an image of the head, face, teeth, and neck. Participants will stand still or sit on a chair for about 20 minutes while the scanner rotates around the head. Photos of the head and face Offsite participants will provide: Copies of medical and dental records Leftover tissue samples from previous surgery Blood sample or cheek swab

Official Title

Natural History of Craniofacial Anomalies and Developmental Growth Variants

Quick Facts

Study Start:2016-04-18
Study Completion:2046-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02639312

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.

Ages Eligible for Study:2 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 2 to \< 100 with craniofacial anomalies/abnormalities. Affected family member (defined as an individual with a demonstrable relationship, any family relationship no matter how distant, with the above subject in the pedigree) who expresses craniofacial anomalies will be classified as a subject.
  2. * Able to provide consent or in the case, of minors, have a legally-authorized representative to provide consent.
  3. * These family members are defined as individuals with a demonstrable relationship (any family relationship no matter how distant) with a proband subject by pedigree who do not express craniofacial anomalies.
  4. * \>= 2 years old to \<= 100 years old.
  5. * Able to provide consent or in the case, of minors, have a legally-authorized representative to provide consent.
  6. * In good general health.
  7. * Able to provide consent or in the case, of minors, have a legally-authorized representative to provide consent.
  8. * Absence of a craniofacial congenital anomaly or malocclusion.
  9. * No family history of a craniofacial syndrome.
  1. * A history of facial trauma requiring surgical treatment and facial reconstruction.
  2. * Refusal for both genetic testing and CBCT imaging. Participants must agree to at least one of the two (both are not required to participate).

Contacts and Locations

Study Contact

Pamela M Orzechowski, R.N.
CONTACT
(301) 402-7373
ps363q@nih.gov
Konstantinia Almpani, D.D.S.
CONTACT
(301) 827-1647
nadine.almpani@nih.gov

Principal Investigator

Konstantinia Almpani, D.D.S.
PRINCIPAL_INVESTIGATOR
National Institute of Dental and Craniofacial Research (NIDCR)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

  • Konstantinia Almpani, D.D.S., PRINCIPAL_INVESTIGATOR, National Institute of Dental and Craniofacial Research (NIDCR)

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 Registration Dates

Study Start Date2016-04-18
Study Completion Date2046-12-31

Study Record Updates

Study Start Date2016-04-18
Study Completion Date2046-12-31

Terms related to this study

Keywords Provided by Researchers

  • Craniofacial
  • Microsomia
  • Mandibular
  • Facial Defects
  • Hasburg Jaw
  • Natural History

Additional Relevant MeSH Terms

  • Prognathism
  • Retrognathism
  • Dentofacial Deformities