Impact of a Process Intervention on Screening and Testing Outcomes for Common Hereditary Cancer Syndromes
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ClinicalTrials.gov Identifier: NCT03081455 |
Recruitment Status :
Completed
First Posted : March 16, 2017
Last Update Posted : August 8, 2017
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Condition or disease | Intervention/treatment |
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Hereditary Cancer | Diagnostic Test: Diagnostic Test |
Study Type : | Observational |
Actual Enrollment : | 145 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective Evaluation of the Impact of a Process Engineering Intervention on Screening and Testing Outcomes for Common Hereditary Cancer Syndromes in Community-Based Obstetrics and Gynecology Settings |
Actual Study Start Date : | February 13, 2017 |
Actual Primary Completion Date : | July 7, 2017 |
Actual Study Completion Date : | August 4, 2017 |

Group/Cohort | Intervention/treatment |
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Women meeting guidelines for genetic testing
Women who present for an OB/GYN office visit (new patient visit, well woman visit, or problem visit) and who meet guidelines for genetic diagnostic testing will provide a blood or saliva sample for genetic diagnostic testing and complete a satisfaction survey.
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Diagnostic Test: Diagnostic Test
Genetic Diagnostic Testing |
- The percentage of previously untested patients meeting guidelines who are offered genetic testing on site. [ Time Frame: Baseline ]The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.
- The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor. [ Time Frame: Baseline ]The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patient who presents for a new patient gynecologic visit, well woman exam, or problem gynecologic visit and meets guidelines (HBOC-NCCN guidelines; Lynch syndrome-SGO/ACOG guidelines) for genetic testing
- Patient who is 18 years of age or older
- Able to understand informed consent and agrees to participate
Exclusion Criteria:
- Patient who has previously undergone BRCA1/2, Lynch syndrome genetic testing, or multi-gene, pan-cancer, or panel testing
- Patient who is not pregnant
- Patient who is unwilling or unable to provide informed consent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081455
United States, Connecticut | |
Westwood Women's Health | |
Waterbury, Connecticut, United States, 06708 | |
United States, New York | |
Associates for Women's Medicine | |
Syracuse, New York, United States, 13203 |
Study Director: | Rocye T. Adkins, MD | Myriad Genetics, Inc. |
Responsible Party: | Myriad Genetic Laboratories, Inc. |
ClinicalTrials.gov Identifier: | NCT03081455 |
Other Study ID Numbers: |
PC-005 |
First Posted: | March 16, 2017 Key Record Dates |
Last Update Posted: | August 8, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Disclosed via peer-reviewed journal |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Screening Hereditary Cancer |
Neoplastic Syndromes, Hereditary Neoplasms Genetic Diseases, Inborn |