Craniofacial Microsomia: Accelerating Understanding of the Significance and Etiology (NCT04351893) | Clinical Trial Compass
CompletedNot Applicable
Craniofacial Microsomia: Accelerating Understanding of the Significance and Etiology
United States, Colombia935 participantsStarted 2018-02-23
Plain-language 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 parents are invited to participate. Children and parents are asked to provide a DNA sample (blood or saliva) and are asked to upload a few photos of their face. Parents are asked a short interview. Participants are able to participate from home or at one of four domestic sites.
Who can participate
Age range0 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Cas…
What they're measuring
1
Identify Genetic Variants
Timeframe: Through study completion, an average of 1 year.