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The purpose of this research study is to see if offering genetic testing for cancer-related genes is feasible and acceptable for patients presenting for gynecology clinic visits, instead of needing to see specialized providers or needing to meet specific criteria. The primary aim to assess the proportion of patients who undergo genetic testing, and the proportion of patients with pathogenic variants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Completed genetic screening test | Experimental | Participants will complete point-of-care genetic testing by saliva test. Participants with actionable pathogenic variants will be referred to the appropriate specialists to discuss risk-reduction strategies and offered genetic counseling. All Participants will be given the opportunity for genetic counseling, and if interested and desired this will be facilitated by the research team. |
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| Denied genetic screening test | No Intervention | Participants in this arm have declined the genetic screening test. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natera® Empower™ hereditary cancer panel test | Genetic | The test will be the Natera® Empower™ hereditary cancer panel test and will be collected by saliva. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who undergo genetic testing | Outcome measure will be assessed via review of electronic medical record (EMR). | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with pathogenic variants | Outcome measure will be assessed via review of Natera® Empower™ hereditary cancer panel test results. | Up to 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bhavana Pothuri, MD, MS | Contact | 212-731-6455 | Bhanava.pothuri@nyulangone.org | |
| Sarah Lee | Contact | 646-501-7876 | Sarah.lee@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Bhavana Pothuri, MD, MS | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: bhavana.pothuri@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to bhavana.pothuri@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Specialist Referral | Other | Participants with actionable pathogenic variants will be referred to the appropriate specialists (e.g., medical oncologist, gynecologic oncologist, breast surgeon) to discuss risk-reduction strategies and offered genetic counseling |
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