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Feasibility Trial of Combined Cancer and Obstetrical Genetic Screening

This study is looking at whether it's practical to offer genetic testing for hereditary cancers (like breast or ovarian cancer) at the same time as standard obstetrical carrier screening (OCS), which checks for genetic conditions that could be passed to a baby. Researchers want to see if women receiving prenatal or preconception care are interested in adding the Natera Empower Comprehensive Hereditary Cancer Panel to their existing OCS. The main goal is to find out what percentage of participants complete both types of screening. This study is for women aged 18 to 55 who are receiving obstetrical care at a CUMC-affiliated site and are already planning to have OCS. The current status of this study is unclear.

Study design
This study plans to enroll 1000 women. It is an interventional study, meaning participants will receive specific interventions.
What's involved
You would meet with a clinician to discuss options for hereditary cancer screening, and if interested, a study coordinator would offer participation. You would receive counseling on genetic testing risks and benefits, and have blood drawn for OCS and potentially the Natera Empower Hereditary Cancer Panel.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, measuring the percentage of participants who complete both screenings, is expected at the end of recruitment, approximately 2 years.

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NCT07195071

Feasibility Trial of Combination of Obstetrical Carrier Screening and Hereditary Cancer Screening

Recruiting
NAAges 18–55InterventionalScreening
Columbia University
~1,000 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:Natera empower comprehensive hereditary cancer panelObstetrical carrier screening

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Who Complete Both HCS and OCS
Measured over Approximately at the end of recruitment, expected at 2 years

Conditions

Hereditary Cancer Syndrome

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Hereditary Neoplastic Syndrome

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Shayan Dioun, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Jessica Giordano
[email protected]
212-305-7250
Email the study team

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Eligibility criteria

Inclusion

Age: 18 years - 55 years
Patients receiving obstetrical-related care at a CUMC-affiliated enrollment site
Patients who have elected to undergo OCS with the CUMC-affiliated obstetrics provider
Patients with prior OCS but planned to repeat OCS are eligible
Patients can speak and read in English or Spanish

Exclusion

Patients who have previously completed a multigene hereditary cancer syndrome panel
Patients that have a hematologic cancer or hematologic pre-cancer
Patients who have a history of an autologous bone marrow transplant

What this trial measures

  • Percentage of Participants Who Complete Both HCS and OCSApproximately at the end of recruitment, expected at 2 years

    The percent of patients who complete hereditary cancer screening (HCS) when offered in addition to routine obstetrical carrier screening (OCS) during preconception and obstetrical-related care.