A Study to Collect Maternal Blood Samples to Isolate DNA for Prenatal Screening (NIPS) in Patients Undergoing Prenatal Chromosomal Testing

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-007750
    Sponsor Protocol Number: 17-007750

About this study

The purpose of this study is to collect maternal peripheral blood samples to isolate cell-free DNA to be used for non-invasive prenatal screening (NIPS) in patients undergoing diagnostic prenatal chromosomal microarray testing on chorionic villi or amniotic fluid samples, thereby having a diagnostic result to correlate with the screening result from NIPS.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Women undergoing CVS or amniocentesis for genomic testing (chromosomal microarray, test CMAP)

Exclusion Criteria: 

  • Pregnant patients under age 18

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nicole Hoppman, Ph.D.

Open for enrollment

Contact information:

Cassandra Runke M.S., LCGC

(507)284-9445

Runke.Cassandra@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available