Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT04351893
Eligibility Criteria:
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.
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
18 Years
Study:
NCT04351893
Study Brief:
Protocol Section:
NCT04351893