AMNIOmics: A Prenatal Rapid Genome Validation Study

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05834621
Collaborator
(none)
90
1
59
1.5

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
AMNIOmics: A Prenatal Rapid Genome Validation Study
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2028
Anticipated Study Completion Date :
Apr 1, 2028

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Enrollment of study participants [5 years]

    To recruit up to 90 total participants including child and both parents

  3. Collection of Biospecimens [5 years]

    Total number of biospecimens collected which may include both blood samples and amniotic fluid

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Minnesota Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Myra Wick, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Myra J. Wick, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05834621
Other Study ID Numbers:
  • 22-002719
First Posted:
Apr 28, 2023
Last Update Posted:
May 2, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2023