Fetal Alcohol Spectrum Disorders Clinical Trial
— DiGFASDOfficial title:
Dissecting the Genetics of Fetal Alcohol Spectrum Disorders
Verified date | May 2023 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to help scientists understand why some people who were exposed to alcohol in the womb have special facial features but other people do not. This study will test if genetics (or DNA) explains these differences. We hope this will help improve treatments and interventions for people with fetal alcohol spectrum disorders (FASD). Participants in this study (or their parents or legal guardians) will be asked to: - Answer some questions about themselves. These questions ask about their demographic background (such as gender, race, ethnicity, income, and education), their health history, and their mother's health during her pregnancy with them (if that information is known). - Speak with study staff briefly by phone or video chat to confirm enrollment in the study and ask any questions they have. - Take photographs of their face. - Provide a saliva sample for genetic research. Participants can complete the study at home from anywhere in the world. The questions can be answered online, over the phone, or on paper. Adopted families are welcome to enroll. The study pays for all shipping costs.
Status | Completed |
Enrollment | 751 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Month to 110 Years |
Eligibility | Inclusion Criteria: - Documented or suspected history of prenatal alcohol exposure OR Fetal Alcohol Spectrum Disorder (FASD) diagnosis - Speaks English Exclusion Criteria: - No documented or suspected history of prenatal alcohol exposure OR FASD diagnosis - Does not speak English |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Facial Risk Score | Facial Risk Score
Each participant's facial images will be evaluated and a Facial Risk Score will be assigned to each individual. This risk score is relative to all individuals participating in the study, and therefore will be updated at the end of each year. Final scores will be completed at the end of the study. The risk score is computer-based, with high scores indicating increased dysmorphology and low scores indicating decreased dysmorphology. |
through study completion, an average of 1 year | |
Primary | Whole Exome Sequencing (WES) | Whole Exome Sequencing
After Facial Risk Scores have been assigned to each individual, two subsets of the study population will be selected: those with high risk scores, and those with low risk scores. Saliva samples from these subpopulations will be subjected to Whole Exome Sequencing (WES). Rare variant analysis will be performed in each gene to evaluate whether there are more rare variants in individuals from one group (e.g., high risk scores) compared to the other group (e.g., low risk scores). This will enable us to determine if the variant increases risk (more common in those with high risk scores) or increases resilience (more common in those with low risk scores). |
through study completion, an average of 1 year |
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