Family Members Clinical Trial
Official title:
AMNIOmics: A Prenatal Rapid Genome Validation Study
NCT number | NCT05834621 |
Other study ID # | 22-002719 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | April 2028 |
Verified date | November 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to validate Whole Genome Sequencing (WGS) on amniotic fluid to reduce the time to diagnosis and enhance the care for the fetus/neonate.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | April 2028 |
Est. primary completion date | April 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria - Fetus with multiple anomalies/suspected genetic disease. - Pregnant patient already planning on having an amniocentesis for another reason separate from this study. Exclusion Criteria - Parents under the age of 18. - Parents lacking the capacity to consent. - Institutionalized (i.e., Federal Medical Prison). |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Minnesota | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validation of Rapid Whole Genome Sequencing technology on amniotic fluid samples | Collection of both amniotic fluid and blood samples to compare results of whole genome sequencing for a fetus with suspected genetic disease. | 5 years | |
Primary | Enrollment of study participants | To recruit up to 90 total participants including child and both parents | 5 years | |
Primary | Collection of Biospecimens | Total number of biospecimens collected which may include both blood samples and amniotic fluid | 5 years |
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