TMIST Sets Quarterly Accrual Record in Q4 2020
Despite the ongoing COVID-19 pandemic and the holiday season, the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) posted its three highest monthly enrollments in the fourth quarter of 2020 (Oct.–Dec.).

Since non-urgent care resumed in most parts of the United States on or around July 1, TMIST has enrolled more participants than all other National Cancer Institute (NIH) trials combined. At year-end, the study had enrolled 37,893 participants at 105 sites in the United States and worldwide.

At a time when organized medicine is working to achieve healthcare equity, TMIST is one of the most inclusive clinical trials ever performed. Nearly 20% of the enrollees from the United States are Black women. The average Black cohort in U.S. clinical trials is approximately 8%.

Do you know of breast imaging facilities that are interested in opening this trial? If so, please encourage them to email [email protected] for a conversation about the study requirements, reimbursement/payment structure and/or to start the application process. This trial continues to recruit new sites!

Pathology Materials Submission Reminder
Please submit the pathology report, representative diagnostic slide(s) and tissue block (if available) for all breast surgeries and breast biopsies (whether malignant or benign) as soon as possible after the procedure. The ECOG-ACRIN® Translational Science Team is reaching out to sites with overdue pathology submissions. If specific issues are routinely delaying your site’s pathology materials submission (greater than 90 days from the procedure), please notify the ECOG-ACRIN Translational Science Team at [email protected].

Blood & Buccal Collection Reminder
TMIST sites are required to be able to collect blood and buccal samples from women who consent to providing these samples. Please develop a site plan for collection, processing and storing samples as detailed in the TMIST Biospecimen Collection and Submission Instructions for Sites. Please collect samples as soon as possible after enrolling participants in TMIST.

Enrollment Continues, New Sites Join as TMIST Leaders Work with NCI Review Committee
The National Cancer Institute (NCI) launched a TMIST review to more efficiently reach study endpoints. The NCI is not ending TMIST. The study remains active. Sites should continue to enroll women. New sites should continue the onboarding process. Send questions to [email protected].

Remote Consent is Still Allowed for TMIST
For full details on the approved remote consent process, see CIRB FAQ 8 and 9.

Restart TMIST at Your Site
Please email [email protected] when your site resumes TMIST enrollment. Sites must resume TMIST quality control (QC) before restarting screening. Email [email protected] when you restart TMIST physics QC.

COVID-19 Related AE Reporting and Protocol Deviations
All COVID-19 related events must be reported in RAVE (login required) — even if not reportable under the TMIST protocol. Events that meet expedited reporting criteria per the protocol must also be reported via CTEP-AERS.   

If you have any questions related to COVID-19 AE reporting or protocol deviation reporting due to COVID-19, email [email protected] and [email protected].   

Please see latest memo on the CTSU site dated June 30: Memorandum: EA1151 Protocol-Specific Deviation Guidance for COVID-19 Mitigation (login to members’ website required).