Multiple Anomalies of FetusNCT05834621
AMNIOmics: A Prenatal Rapid Genome Validation Study
An observational study of Multiple Anomalies of Fetus and Genetic Predisposition Suspected, run by Mayo Clinic.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Anomalies of Fetus, Genetic Predisposition Suspected, Amniocentesis Affecting Fetus or Newborn
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2025to 7 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be identified internally through provider referrals most commonly through the Mayo Clinic Obstetrical and Maternal Fetal Medicine services.
Who may be able to join
- Fetus with multiple anomalies/suspected genetic disease.
- Pregnant patient already planning on having an amniocentesis for another reason separate from this study.
Who cannot join
- Parents under the age of 18.
- Parents lacking the capacity to consent.
- Institutionalized (i.e., Federal Medical Prison).
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Enrollment of study participants
To recruit up to 90 total participants including child and both parents
Measured: 5 years
Collection of Biospecimens
Total number of biospecimens collected which may include both blood samples and amniotic fluid
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start7 Jan 2025
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Why it stopped: No patients were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Anomalies of FetusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myra J. Wick, Mayo Clinic
- Investigators
- Myra Wick, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834621
- Sponsor's protocol ID
- 22-002719
- Status last verified
- Aug 2025
- First submitted
- 4 Apr 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMNIOmics: A Prenatal Rapid Genome Validation Study
- ClinicalTrials.gov ID
- NCT05834621
- Acronym / sponsor ID
- 22-002719
- Conditions
- Multiple Anomalies of Fetus, Genetic Predisposition Suspected, Amniocentesis Affecting Fetus or Newborn, Family Members
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be identified internally through provider referrals most commonly through the Mayo Clinic Obstetrical and Maternal Fetal Medicine services.
Key inclusion criteria (2 listed)
- Fetus with multiple anomalies/suspected genetic disease.
- Pregnant patient already planning on having an amniocentesis for another reason separate from this study.
Key exclusion criteria (3 listed)
- Parents under the age of 18.
- Parents lacking the capacity to consent.
- Institutionalized (i.e., Federal Medical Prison).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of Rapid Whole Genome Sequencing technology on amniotic fluid samples
Time frame: 5 years
Collection of both amniotic fluid and blood samples to compare results of whole genome sequencing for a fetus with suspected genetic disease.
Enrollment of study participants
Time frame: 5 years
To recruit up to 90 total participants including child and both parents
Collection of Biospecimens
Time frame: 5 years
Total number of biospecimens collected which may include both blood samples and amniotic fluid
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myra Wick, MD, PhD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Anomalies of Fetus and Genetic Predisposition Suspected, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of Rapid Whole Genome Sequencing technology on amniotic fluid samples (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.