Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
ID07052266

Feasibility of Combined Obstetric Carrier and Hereditary Cancer Screening During Prenatal and Preconception Care

Led by Weill Medical College of Cornell University · Updated on 2025-12-26

550

Participants Needed

5

Research Sites

78 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

M

Myriad Genetics, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the interest and acceptability of adding hereditary cancer screening (HCS) alongside standard obstetric carrier screening (OCS) among women receiving routine prenatal or preconception/fertility care. The study addresses the opportunity pregnancy offers for early cancer prevention, particularly in underserved populations, by assessing whether universal screening during this time is feasible and potentially cost-effective. It focuses on BRCA1/2 genetic testing, which is not typically included in standard OCS despite its importance for cancer risk assessment. Participants will be offered combined HCS and OCS either during obstetrical/prenatal visits or at reproductive endocrinology and infertility clinics. If they choose to proceed with OCS, a genetics clinician will provide counseling about HCS, including its risks, benefits, and possible outcomes. This trial evaluates patient decisions to accept HCS in addition to OCS and follows established counseling and consent procedures. During the study, researchers will track how many participants complete both HCS and OCS tests within about two years. They will also measure participant experiences through various questionnaires and interviews, including distress levels and satisfaction with genetic counseling and decision-making. High-risk participants will be monitored for use of cancer prevention strategies up to 18 months after screening. Provider experiences will also be collected. Overall, the study lasts through recruitment and follow-up periods, aiming to understand acceptability and outcomes of combined genetic screening.

CONDITIONS

Brief Title

Trial of Combined Obstetric Carrier Screening and Hereditary Cancer Screening

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years to 55 years
  • Pregnant patients receiving obstetrical-related care or patients receiving preconception/fertility care at a WCM-affiliated site
  • Patients who have elected to undergo obstetric carrier screening with a WCM-affiliated obstetrics provider
  • Patients with prior obstetric carrier screening but planning to repeat it are eligible
  • Patients must be able to speak and read English or Spanish
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person or by telephone)

Treatment

Duration - Up to 2 years or until recruitment ends

Participants receive combined hereditary cancer screening (HCS) and obstetric carrier screening (OCS) during prenatal or preconception care. A genetics clinician provides counseling on the risks, benefits, and implications of HCS.

1 genetics counseling session (in-person or by telephone) plus OCS during standard prenatal or preconception care visits

Follow-up

Duration - Up to 18 months after screening completion

Participants are followed to assess utilization of cancer risk mitigation strategies and to gather feedback on their experience with combined HCS and OCS.

Questionnaires and interviews conducted following genetic counseling and screening

Trial Site Locations

Total: 5 locations

1

Reproductive Medicine

Brooklyn, New York, United States, 11201

Actively Recruiting

2

NewYork-Presbyterian Weill Cornell Medicine

Brooklyn, New York, United States, 11215

Not Yet Recruiting

3

Reproductive Medicine

New York, New York, United States, 10021

Actively Recruiting

4

Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

5

NewYork-Presbyterian Weill Cornell Medicine Queens

Queens, New York, United States, 11355

Actively Recruiting

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Research Team

S

Steve Lopez, BA

R

Ravi Sharaf, MD, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Interest in Cancer Predisposition Testing and Carrier Screening Offered as Part of Routine Healthcare Among an Ethnically Diverse Sample of Young Women.

Kimberly A Kaphingst, Jemar R Bather, Brianne M Daly...

https://pubmed.ncbi.nlm.nih.gov/35495140

Investigation of interest in and timing preference for cancer predisposition testing and expanded carrier screening among women of reproductive age.

Lingzi Zhong, Jemar R Bather, Brianne M Daly...

https://pubmed.ncbi.nlm.nih.gov/37214524

Expanded carrier screening in reproductive medicine-points to consider: a joint statement of the American College of Medical Genetics and Genomics, American College of Obstetricians and Gynecologists, National Society of Genetic Counselors, Perinatal Quality Foundation, and Society for Maternal-Fetal Medicine.

Janice G Edwards, Gerald Feldman, James Goldberg...

https://pubmed.ncbi.nlm.nih.gov/25730230

Receipt of Selected Preventive Health Services for Women and Men of Reproductive Age - United States, 2011-2013.

Karen Pazol, Cheryl L Robbins, Lindsey I Black...

https://pubmed.ncbi.nlm.nih.gov/29073129