Encrypted and Special Variables
The patient's county of residence is available on the Cancer File (FIP codes) and state of residence is available on the Medicaid Enrollment File. To protect patient and provider identification, NCI encrypts other geographic variables including patient's census tract. Separate files that contain geographically-based (census tract level) socioeconomic information from the 1990 and 2000 Censuses and the 2008 – 2012 American Community Survey are provided and can be matched by the encrypted patient census tract available in the Cancer File. Unencrypted census tracts are not available for release at this time.
Breast Cancer Oncotype Dx
Exact Sciences (formerly Genomic Health) developed the Oncotype DX Breast Recurrence Score® assay (Assay), which is a commercial diagnostic test that predicts 10-year distant recurrence risk based on the expression of 21 genes. The resulting recurrence score is used to better weigh the harms and benefits of chemotherapy, thereby informing treatment decisions. The Assay data are linked to SEER data via a collaboration between NCI and Exact Sciences, with IMS acting as the third party, honest broker. The Assay variables that have been linked to SEER data include: Assay, Assay risk group, Assay reason no score, Assay test report date, and Assay months since diagnosis (Appendix A). Note: Per the agreement with Exact Sciences, NCI all approved applications requesting Oncotype Dx variables and any manuscripts or reports that result from the analyses of such data will be shared with Exact Sciences. These documents will be shared with Exact Sciences for informational purposed only; all approval decisions will be handled by NCI.
If investigators determine that they want the Oncotype DX Breast cancer variables they must explicitly provide justification for these variables in their application.
*NOTE: variation in multigene signature method have been observed (e.g., by geographic region and calendar year); this variation should be taken into consideration during study design and interpretation.