NCT07610590 guideSEQ: Genomic Understanding, Impact, Decision & Ethics in Prenatal Sequencing
| NCT ID | NCT07610590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Prenatal Genetic Diagnosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,042 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2029-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,042 participants in total. It began in 2026-04-29 with a primary completion date of 2029-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study looks at whether genome sequencing should be used more routinely during pregnancy, even when ultrasounds look normal. Genome sequencing can examine nearly all of a baby's genes and may find genetic conditions that standard tests do not detect. Researchers will compare this test with current prenatal testing to see if it provides helpful information for families and doctors. The study will also explore how parents decide what kinds of genetic information they want to receive and how this information affects their experience during pregnancy. The goal is to understand whether genome sequencing can be used in a way that is helpful, responsible, and supportive for families in the future.
Eligibility Criteria
Inclusion Criteria: * Patient planned chorionic villus sampling (CVS) or amniocentesis in the absence of major fetal structural anomalies (minor anomalies are eligible, the HPO (Human Phenotype Ontology) will not be used by the analyst) * Certified genetic counselor involved in care Exclusion Criteria: * A major structural anomaly * Maternal or paternal age less than 18 years old * Parental unwillingness to participate in 1 year of postnatal follow-up * Language barrier (non-English or Spanish speaking)
Contact & Investigator
Ronald Wapner, MD
PRINCIPAL INVESTIGATOR
Columbia University Irving Medical Center (CUIMC)
Frequently Asked Questions
Who can join the NCT07610590 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prenatal Genetic Diagnosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07610590 currently recruiting?
Yes, NCT07610590 is actively recruiting participants. Contact the research team at cz2888@cumc.columbia.edu for enrollment information.
Where is the NCT07610590 trial being conducted?
This trial is being conducted at Boston, United States, New York, United States, New York, United States.
Who is sponsoring the NCT07610590 clinical trial?
NCT07610590 is sponsored by Columbia University. The principal investigator is Ronald Wapner, MD at Columbia University Irving Medical Center (CUIMC). The trial plans to enroll 1,042 participants.