Evaluating a Novel Onco-genetic BRCA Testing Counselling Model Among Patients With Ovarian Cancer
NCT ID: NCT02406235
Last Updated: 2017-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
710 participants
OBSERVATIONAL
2015-04-21
2016-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
No
Sponsors
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Optum, Inc.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
San Francisco, California, United States
Research Site
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
Napoli, 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
Countries
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References
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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.
Related Links
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D0816R00006\_CSR\_Synopsis.pdf
Other Identifiers
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D0816R00006
Identifier Type: -
Identifier Source: org_study_id