New diagnosis of stage I-III breast cancer, surgery at BWH, chemotherapy at DFCI Yes Yes New diagnosis of stage I-III breast cancer, surgery at MGH, chemotherapy at MGH Yes No New diagnosis of stage I-III breast cancer, surgery at outside hospital, chemotherapy at DFCI Yes No New diagnosis of stage I-III breast cancer, second opinion only, not treated at DFCI or MGH No No New diagnosis of stage I-III breast cancer, surgery at Faulkner Hospital, chemotherapy at DFCI Yes Yes New diagnosis of stage I-III breast cancer, surgery at Faulkner Hospital, no treatment at DFCI or BWH main campus No Yes New diagnosis of de novo metastatic breast cancer, treated at DFCI Yes Yes New diagnosis of recurrent metastatic breast cancer, previous treatment for stage II breast cancer at outside hospital No No Presenting for second opinion for second line therapy for metastatic breast cancer, consult only No No Presenting for second opinion for second line therapy for metastatic breast cancer (treated elsewhere prior), and subsequently transfers care to DFCI No No 11-104: Profile - Research on Clinically Acquired Patient Material in Cancer Principal Investigator – Bruce Johnson, MD Overall Accrual: 594 - Oncomap testing, 1,130 - Oncopanel testing Accrual of patients with primary diagnosis of breast cancer: XX 11-104 (Profile) is the umbrella protocol for clinical data, tissue collection and genomic testing of tumors across DFCI, BWH, and Boston’s Children’s Hospital. Patients have been consented since 2011. There have been different versions of the assay used since 2011. The Oncomap assay was used from 8/01/2011 through the end of September 2013 from DFCI (adult and pediatric), BWH (Adults) and consult patients referred from other hospitals to DFCI and BWH are included. Three versions of OncoPanel tests are included in the database:OncoPanel Version 1 (v1) data includes patients sequenced between 6/26/2013 and 8/6/2014. Oncopanel
work to the DF/HCC IRB. Please refer to the OHRS website for details of submission and application templates for IRB review of low risk protocols. How do I submit a research proposal? Depending on the request type for clinical data and/or tissue, the submission of your research proposal to Users Committee (and IRB if applicable) will have different requirements. Please refer to the section, “Do I need to submit through OncDRS, the Users committee, or both” for additional details. Request Type for clinical data and/or specimens OncDRS Request form Users Committee (paper application) IRB Aggregate data (e.g. number of eligible patients with clinical data/specimens) No, can either directly access OncDRS aggregate query tool or complete Clinical Research Data Request form. No No De-identified data for feasibility analysis Yes No Must agree not to publish or identify patients without Users Committee approval No De-identified clinical data Yes, an option for DFCI based investigators, and replaces users committee paper application Yes. (Note, if OncDRS is used, an additional paper application is not required) No Identified Retrospective data, discrete data elements Yes, an option for DFCI based investigators, and replaces users committee paper application Yes. (Note, if OncDRS is used, an additional paper application is not required) Yes. Either complete OncDRS application which will then automatically route to IRB after users committee approval is granted (only available for investigators). Or, submit users committee application by email and a separate IRB protocol. Identified data (which may or may not require retrospective data), with plan for continued prospective data collection for additional data elements No Yes Yes. Studies that intend to collect data from identified patients (for example, a prospective cohort study) require an IRB protocol and approval and cannot be submitted solely through OncDRS. Complete users committee application and complete “New Project Application: Research use of retrospective medical records or previously collected specimens.”