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| Name | Class |
|---|---|
| Optum, Inc. | INDUSTRY |
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The overall objective of this study is to assess turnaround time, pre-BRCA test onco-genetic counselling quality and satisfaction with a new onco-genetic BRCA testing model.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Assessing turnaround time with the new BRCA-testing pathway | 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer prior to, or at enrolment in this study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Francisco | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29558274 | Derived | Colombo N, Huang G, Scambia G, Chalas E, Pignata S, Fiorica J, Van Le L, Ghamande S, Gonzalez-Santiago S, Bover I, Grana Suarez B, Green A, Huot-Marchand P, Bourhis Y, Karve S, Blakeley C. Evaluation of a Streamlined Oncologist-Led BRCA Mutation Testing and Counseling Model for Patients With Ovarian Cancer. J Clin Oncol. 2018 May 1;36(13):1300-1307. doi: 10.1200/JCO.2017.76.2781. Epub 2018 Mar 20. |
| Label | URL |
|---|---|
| D0816R00006\_CSR\_Synopsis.pdf | View source |
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| Gainesville |
| Florida |
| United States |
| Research Site | Sarasota | Florida | United States |
| Research Site | Augusta | Georgia | United States |
| Research Site | Worcester | Massachusetts | United States |
| Research Site | Hackensack | New York | United States |
| Research Site | Lake Success | New York | United States |
| Research Site | Mineola | New York | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | Chapel Hill | North Carolina | United States |
| Research Site | Providence | Rhode Island | United States |
| Research Site | Brescia | IT | Italy |
| Research Site | Genova | IT | Italy |
| Research Site | Milan | IT | Italy |
| Research Site | Modena | IT | Italy |
| Research Site | Naples | IT | Italy |
| Research Site | Roma | IT | Italy |
| Research Site | Torino | IT | Italy |
| Research Site | A Coruña | SP | Spain |
| Research Site | Barcelona | SP | Spain |
| Research Site | Cáceres | SP | Spain |
| Research Site | Córdoba | SP | Spain |
| Research Site | Madrid | SP | Spain |
| Research Site | Murcia | SP | Spain |
| Research Site | Palma de Mallorca | SP | Spain |
| Research Site | Zaragoza | SP | Spain |