NCT07195071 · Columbia University
Feasibility Trial of Combination of Obstetrical Carrier Screening and Hereditary Cancer Screening
(FOCUS)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Natera empower comprehensive hereditary cancer panel
Natera Empower Comprehensive Hereditary Cancer Panel to screen for hereditary cancers
DEVICE
Obstetrical carrier screening
Obstetrical carrier screening for genetic conditions
Primary outcome measures
Percentage of Participants Who Complete Both HCS and OCS
Time frame: Approximately 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Collaborators
Natera, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations