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

NCT ID: NCT07195071

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

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

Detailed Description

In this prospective trial, a clinician in the department of OBGYN will meet with preconception/pregnant patients who are undergoing obstetrical carrier screening (OCS) at Columbia University affiliated OBGYN clinics to review the options for concurrent hereditary cancer screening (HCS). If interested in the study, the patient will be contacted by a study coordinator and offered participation in the study. The patients will have counseling on potential risks and benefits of genetics testing and have OCS performed per standard of care protocols. This consultation will include collection of comprehensive personal and family history to generate a cancer genetic risk assessment. The patient will be counseled based on their cancer genetic risk assessment, whether or not National Comprehensive Cancer Network (NCCN) guidelines for cancer risk assessment are met and the resulting anticipated cost. The patient will be offered additional consultation with a genetic counselor and/or a Natera financial representative if desired for further counseling. If the patient decides to proceed with HCS, the Natera Empower Hereditary Cancer Panel will be drawn at the time of the OCS panel blood draw and sent to Natera for processing. OCS results will be sent separately and reported to the patient based on standard protocols. Patients that have HCS panels sent will be notified of their results by a genetic counselor from Columbia University's Department of OBGYN and standard of care post test counseling/referrals made.

The study team will evaluate patient acceptance of testing and the patient experience, via validated surveys conducted at time of testing. The study team will evaluate if patient sociodemographic characteristic (e.g. age, parity, race, ethnicity, medical history, family history) are associated with patient acceptance of the combined OCS/HSC panel. Patients that elect to undergo HCS panel will also complete the Regret About Healthcare Decisions Survey after receiving their HCS results. Participation in surveys is encouraged but not mandatory. All patient demographics, survey screens and results will be stored in a secure online database maintained by Columbia University's Department of OBGYN. This data will be entered and maintained by study personal at Columbia University. Patients enrolled in the study will be invited to participate in an interview conducted by telephone at times convenient for them. Interviews will be conducted by language-concordant, trained qualitative experts. Interviews will be recorded and transcribed. Participation in the interview is not mandatory.

Patients that completed HCS and had a mutation that resulted in a recommendation for clinical follow up (e.g. BRCA 1/2 mutation with recommendation for breast screening) will be contacted by telephone at 18 months and asked whether they completed the medical follow-up prompted by HCS results. Participation in this follow-up is not mandatory.

Conditions

Hereditary Cancer Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Arm A: Hereditary cancer testing

Hereditary Cancer screenings testing and Obstetric Cancer Screening

Group Type: EXPERIMENTAL

Natera empower comprehensive hereditary cancer panel

Intervention Type: DEVICE

Natera Empower Comprehensive Hereditary Cancer Panel to screen for hereditary cancers

Obstetrical carrier screening

Intervention Type: DEVICE

Obstetrical carrier screening for genetic conditions

Arm B: No hereditary caner testing

Obstetric Cancer screening test only

Group Type: ACTIVE_COMPARATOR

Obstetrical carrier screening

Intervention Type: DEVICE

Obstetrical carrier screening for genetic conditions

Interventions

Natera empower comprehensive hereditary cancer panel

Natera Empower Comprehensive Hereditary Cancer Panel to screen for hereditary cancers

Intervention Type: DEVICE

Obstetrical carrier screening

Obstetrical carrier screening for genetic conditions

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Natera, Inc.

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Shayan M. Dioun

Assistant Professor of Obstetrics and Gynecology, Division of Gynecologic Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shayan Dioun, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Central Contacts

Jessica Giordano

Role: CONTACT

jlg2197@cumc.columbia.edu

212-305-7250

Reena Vattakalam

Role: CONTACT

rmv2110@cumc.columbia.edu

212-342-6895

Facility Contacts

Jessica Giordano

Role: primary

jlg2197@cumc.columbia.edu

212-305-7250

Reena M Vattakalam

Role: backup

rmv2110@cumc.columbia.edu

212-342-6895

Other Identifiers

AAAV8327

Identifier Type: -

Identifier Source: org_study_id