An observational study in Breast Cancer, sponsored by British Columbia Cancer Agency. Status unknown at 1 site in Canada. Open to female participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-07-20.
Sponsored by British Columbia Cancer Agency · Observational
This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The Oncotype DX® assay is a commercially available diagnostic test that aids in a physician's treatment recommendation to a breast cancer patient. The study also has a pharmacoeconomic component.
This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The study also has a pharmacoeconomic component. All eligible patients in which either physician and/or patient determine that results from the 21 gene recurrence score could provide additional information useful in the decision making process regarding adjuvant chemotherapy or not will be asked by the participating physicians to participate in the study. If interested, the patient will consent to the study. The physician will complete a baseline questionnaire to document recommended adjuvant systemic therapies (pre-Oncotype DX®). The Oncotype DX® assay will be ordered after receipt of the Physician and Patient Registration and assignment of patient study number. The physician will discuss the results of the Oncotype DX® assay with the patient once the result is available and upon receipt of the pre-test questionnaire. The physician will complete a follow-up questionnaire (to document recommended adjuvant systemic therapies post Oncotype DX®) after the result of the Oncotype DX® assay is known.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 80 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →British Columbia Cancer Agency is the lead sponsor of 149 studies on the registry; 32 are open to participants now.
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Operative Primary Breast Cancer
Exclusion Criteria:
The Oncotype DX® assay is a multi-gene reverse-transcriptase-polymerase-chain-reaction (RT-PCR) test that analyzes the expression of 21 genes, and quantifies the 10 year distant breast cancer recurrence risk in patients with stage I and II, lymph node negative, estrogen receptor positive disease who plan to be treated with tamoxifen for 5 years.
Oncotype DX® assay affect on physician's treatment recommendations assessed by questionnaire
The Oncotype DX® assay affect on physician's treatment recommendations pre and post Oncotype DX® Recurrence Score® result.
Time frame: 1 Month
Assessing Costs differences to the Publicly funded Health Care System
Costs to a publicly funded health care system
Time frame: Data will be analyzed within 8 weeks of enrollment completion and presented within 9 months of study completion
Plan to share: No
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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British Columbia Cancer Agency