Recruiting

Hereditary Cancer Testing

Sponsor:

Columbia University

Code:

NCT07195071

Conditions

Hereditary Cancer Syndrome

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Natera empower comprehensive hereditary cancer panel

Obstetrical carrier screening

Study Details

Brief summary:

The investigators hypothesize that preconception and pregnancy may be a feasible and effective time to offer inherited cancer risk screening. This study will assess interest in cancer genetic testing among patients receiving routine prenatal care or preconception care. The goal is to evaluate the acceptability of hereditary cancer testing when offered alongside standard prenatal genetic screening. The study will also explore whether universal screening in this population could support early cancer prevention

Conditions

Hereditary Cancer Syndrome

Study ID

NCT07195071

Start date

Feb 12, 2026

Status verified date

Feb, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion criteria:

  • 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 criteria:

  • 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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Arm A: Hereditary cancer testing

Hereditary Cancer screenings testing and Obstetric Cancer Screening

active comparator: Arm B: No hereditary caner testing

Obstetric Cancer screening test only

Interventions

Natera empower comprehensive hereditary cancer panel

Natera Empower Comprehensive Hereditary Cancer Panel to screen for hereditary cancers

Obstetrical carrier screening

Obstetrical carrier screening for genetic conditions

Primary outcome measure

  • Percentage of Participants Who Complete Both HCS and OCS [ Time Frame: Approximately at the end of recruitment, expected at 2 years ]

Central Contacts and Locations

Central contacts

Jessica Giordano

212-305-7250jlg2197@cumc.columbia.edu

Reena Vattakalam

212-342-6895rmv2110@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Jessica Giordano

212-305-7250jlg2197@cumc.columbia.edu

Reena M Vattakalam

212-342-6895rmv2110@cumc.columbia.edu

Principal Investigator:

Shayan Dioun, MD

More Information

Sponsor

Columbia University

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • obstetrical carrier screening
  • Pregnant women
  • prenatal screening
  • carrier screening
  • genetic testing
  • hereditary cancer
  • hereditary cancer genetic testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-02-18.