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NCT05834621 Clinical Trial

AMNIOmics: A Prenatal Rapid Genome Validation Study

Family Members Clinical Trial

Official title:
AMNIOmics: A Prenatal Rapid Genome Validation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
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

Study information
Verified date November 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
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).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
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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