- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02406235
Evaluating a Novel Onco-genetic BRCA Testing Counselling Model Among Patients With Ovarian Cancer (ENGAGE)
Evaluating a Novel Onco-genetic BRCA Testing Counselling Model Among Patients With Ovarian Cancer - ENGAGE Study
Study Overview
Status
Detailed Description
This will be a prospective observational study of patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer prior to, or at enrolment in this study. The study is descriptive in nature and does not attempt to test any specific a priori hypotheses.
Clinical teams (physicians and nurses) will be trained to discuss BRCA testing with ovarian cancer patients who meet study criteria and consent to participate in the study. Patients will be recruited from participating sites in North America and Europe. Patients selected per the study inclusion and exclusion criteria will be consented for participation in the study. Patients will be recruited during an estimated 12 month period and participating patients will be followed from enrollment in the study until provision of BRCA test results, final genetics counselling, and completion of satisfaction survey or death. A case report form will be developed to collect information on the primary variable of interest (i.e., turnaround time), patient and disease characteristics, medical history, treatment patterns and outcome of the BRCA test. In addition, a survey will be developed to evaluate patient's assessment of pre- BRCA onco-genetic counseling quality and satisfaction with onco-genetic testing process.
Finally, surveys will be developed to evaluate oncologist (or oncology nurse) and genetic counselor's assessment of the processes associated with the onco-genetic testing pathway.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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IT
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Brescia, IT, Italy
- Research Site
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Genova, IT, Italy
- Research Site
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Milano, IT, Italy
- Research Site
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Modena, IT, Italy
- Research Site
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Napoli, IT, Italy
- Research Site
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Roma, IT, Italy
- Research Site
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Torino, IT, Italy
- Research Site
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SP
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A Coruna, SP, Spain
- Research Site
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Barcelona, SP, Spain
- Research Site
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Caceres, SP, Spain
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Cordoba, SP, Spain
- Research Site
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Madrid, SP, Spain
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Murcia, SP, Spain
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Palma de Mallorca, SP, Spain
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Zaragoza, SP, Spain
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California
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San Francisco, California, United States
- Research Site
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Florida
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Gainesville, Florida, United States
- Research Site
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Sarasota, Florida, United States
- Research Site
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Georgia
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Augusta, Georgia, United States
- Research Site
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Massachusetts
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Worcester, Massachusetts, United States
- Research Site
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New York
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Hackensack, New York, United States
- Research Site
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Lake Success, New York, United States
- Research Site
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Mineola, New York, United States
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The Bronx, New York, United States
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North Carolina
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Chapel Hill, North Carolina, United States
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Rhode Island
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Providence, Rhode Island, United States
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer
- Patients aged 18 years or older at ovarian cancer diagnosis
- Provision of written informed consent
- Patient is able to read, write, and understand the material presented to them as part of this study, per the discretion of the physician
Exclusion Criteria:
- Patients with low grade epithelial ovarian cancer or non-epithelial ovarian cancer
- Patients enrolled in an interventional clinical trial for ovarian cancer or other malignancy at the time of conduct of this study
- Patients with BRCA testing any time prior to the study enrollment
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Assessing turnaround time with the new BRCA-testing pathway
Time Frame: participating patients will be followed from enrollment in the study until provision of BRCA test results, final genetics counselling and completion of satisfaction survey or death, an expected average of 2 months
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The primary objectives include a) assessing turnaround time with the new BRCA (Breast Cancer)-testing pathway; b) patient's assessment of pre-BRCA test onco-genetic counselling quality and satisfaction with the onco-genetic BRCA testing pathway; c) oncologists, and genetic counsellor's assessment of onco-genetic BRCA testing process.
The study will be limited to patients with a diagnosis of ovarian cancer.
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participating patients will be followed from enrollment in the study until provision of BRCA test results, final genetics counselling and completion of satisfaction survey or death, an expected average of 2 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- D0816R00006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Precigen, IncRecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Stage III Fallopian Tube... and other conditionsUnited States