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

NCT07195071 | Recruiting FDA Device

• 1 other identifier: AAAV8327
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Complete Both HCS and OCS

  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.

  Approximately at the end of recruitment, expected at 2 years

Secondary Outcomes (6)

• Score on Regret About Healthcare Decisions survey

  2 to 6 months after enrollment

• Score on Regret About Healthcare Decisions Survey among pregnant participants

  Approximately at the end of recruitment, expected at 2 years

• Score on Regret About Healthcare Decisions Survey among nonpregnant participants

  Approximately at the end of recruitment, expected at 2 years

• Hereditary cancer screening results

  Approximately at the end of recruitment, expected at 2 years

• Percentage of High-Risk Participants Utilizing Guideline-Based Cancer Mitigation Strategies

  18 months after enrollment

Study Arms (2)

Arm A: Hereditary cancer testing

EXPERIMENTAL

Hereditary Cancer screenings testing and Obstetric Cancer Screening

Device: Natera empower comprehensive hereditary cancer panel; Device: Obstetrical carrier screening

Arm B: No hereditary caner testing

ACTIVE COMPARATOR

Obstetric Cancer screening test only

Device: Obstetrical carrier screening

Interventions

Obstetrical carrier screening DEVICE

Obstetrical carrier screening for genetic conditions

Arm A: Hereditary cancer testing; Arm B: No hereditary caner testing

Natera empower comprehensive hereditary cancer panel DEVICE

Natera Empower Comprehensive Hereditary Cancer Panel to screen for hereditary cancers

Arm A: Hereditary cancer testing

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Natera, Inc.: collaborator
• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Neoplastic Syndromes, Hereditary

Condition Hierarchy (Ancestors)

Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shayan Dioun, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Giordano

CONTACT

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

Reena Vattakalam

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology, Division of Gynecologic Oncology

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: February 12, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)