Microtia Clinical Trial
— CAUSEOfficial title:
Craniofacial Microsomia: Accelerating Understanding of the Significance and Etiology
NCT number | NCT04351893 |
Other study ID # | 17-601-E |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 23, 2018 |
Est. completion date | August 30, 2023 |
Verified date | April 2024 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 935 |
Est. completion date | August 30, 2023 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 0 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Colombia | Pontificia Universidad Javeriana | Bogotá | |
Colombia | ICESI | Cali | |
Colombia | Pontificia Universidad Javeriana | Cali | |
Colombia | Clínica Comfamiliar Risaralda | Pereira | |
Peru | Hospital Edgardo Rebagliati Martins | Lima | |
Spain | Instituto de Genética Médica y Molecular (INGEMM) | Madrid | |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Seattle Children's Hospital | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital | Children's Hospital Los Angeles, Children's Hospital of Philadelphia, Clinica Comfamiliar Risaralda, Hospital Nacional Edgardo Rebagliati Martins, Instituto de Investigación Hospital Universitario La Paz, Pontificia Universidad Javeriana, Universidad Icesi, University of North Carolina, Chapel Hill |
United States, Colombia, Peru, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify Genetic Variants | To identify genetic variants related to the CFM spectrum using whole genome sequencing | Through study completion, an average of 1 year. | |
Secondary | Characterize phenotype | To characterize the detailed phenotype in individuals with CFM | Through study completion, an average of 1 year. | |
Secondary | Characterize markers | To characterize ancestry markers in individuals with CFM | Through study completion, an average of 1 year. | |
Secondary | Coding and non-coding variants | To assess coding and non-coding variants in selected candidate genes in individuals with CFM | Through study completion, an average of 1 year. |
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