AMNIOmics: A Prenatal Rapid Genome Validation Study

Not yet recruiting

• Conditions: Amniocentesis Affecting Fetus or Newborn; Multiple Anomalies of Fetus; Genetic Predisposition Suspected; Family Members

• Registration Number: NCT05834621
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Study Start: 2025-07
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Enrollment of study participants	5 years	To recruit up to 90 total participants including child and both parents
Validation of Rapid Whole Genome Sequencing technology on amniotic fluid samples	5 years	Collection of both amniotic fluid and blood samples to compare results of whole genome sequencing for a fetus with suspected genetic disease.
Collection of Biospecimens	5 years	Total number of biospecimens collected which may include both blood samples and amniotic fluid

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States