Status:
COMPLETED
Craniofacial Microsomia: Accelerating Understanding of the Significance and Etiology
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Children's Hospital Los Angeles
Children's Hospital of Philadelphia
Conditions:
Microtia
Microtia-Anotia
Eligibility:
All Genders
Up to 18 years
Brief Summary
The CAUSE study is a multicenter study, with domestic (n=4) and international (n=6) study sites. Children and young adults (ages 0-18) who have microtia and/or craniofacial microsomia and their parent...
Eligibility Criteria
Inclusion
- INCLUSION:
- Cases:
- Participant with CFM is 0-18 years of age
- Participant has diagnosis of at least one of the following conditions:
- Microtia
- Anotia
- Facial asymmetry AND preauricular tag(s)
- Facial asymmetry AND facial tag(s)
- Facial asymmetry AND epibulbar dermoid
- Facial asymmetry AND macrostomia (i.e., lateral cleft)
- Preauricular tag AND epibulbar dermoid
- Preauricular tag AND macrostomia
- Facial Tag AND epibulbar dermoid
- Macrostomia AND epibulbar dermoid
- Participant's parent or legal guardian has provided written informed consent prior to enrollment into study (for participants younger than 18 years of age).
- Participant speaks a language in which they are eligible for consent at their enrolling site
- Parents:
- Parent participant is the biological parent of a case participant already eligible and participating in the CAUSE study. Non-genetic parents will be interviewed about their child's known prenatal and genetic family history but will not be asked to provide DNA or have facial photographs taken.
- Participant speaks a language in which they are eligible for consent at their enrolling site
- Other relatives:
- Other relatives participants, of any age, are related biologically to a case participant already eligible and participating in the CAUSE study from a multiplex family (multiple affected individuals with CFM).
- Participant speaks a language in which they are eligible for consent at their enrolling site
- EXCLUSION:
- Cases:
- Participant is diagnosed with a known syndrome that involves microtia and underdevelopment of the jaw (Townes-Brocks, Treacher-Collins, Branchiootorenal, Nager, or Miller syndromes).
- Participant has abnormal chromosome studies (karyotype).
- Participant has mandibular asymmetry due to deformational plagiocephaly or torticollis.
Exclusion
Key Trial Info
Start Date :
February 23 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
935 Patients enrolled
Trial Details
Trial ID
NCT04351893
Start Date
February 23 2018
End Date
August 30 2023
Last Update
April 22 2024
Active Locations (10)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 90027
4
Seattle Children's Hospital
Seattle, Washington, United States, 98101