TMIST Study Updates.

Under 3,000 Women Left to Enroll
We are reaching our planned enrollment goal! We expect to complete enrollment in either December 2024 or January 2025. To our actively enrolling sites, we are so grateful that you responded to our call to redouble your efforts to reach our goal as quickly as possible. Please continue to enroll whenever possible so that we may finish accrual in 2024!

Amendment #14
Amendment #14 of the TMIST protocol went into effect Aug. 15, 2024. This amendment includes a reduction in sample size to 108,508.

New Site Activations for TMIST Ended July 1, 2024
A fast-growing National Cancer Institute (NCI)-sponsored trial, TMIST no longer needs additional sites as it nears the completion of its accrual period.

Reminder: TMIST Outreach Materials
A variety of news stories about the trial, along with educational and recruitment materials, continue to be posted on the ECOG-ACRIN website. These materials will be available until the trial reaches its planned accrual goal. Please continue to share these resources widely with potential enrollees, cancer research advocates and others in your community.

Blood and Buccal Collection Reminder
TMIST sites must collect blood and buccal samples from women who consent to provide them — as soon as possible after enrolling participants in TMIST, ideally at T0 — and develop a site plan for collection, processing and storing samples [prior login to your Cancer Therapy Evaluation Program (CTEP) — Identity and Access Management (IAM) account integrated with ID.me is required]. Note the new deadline for blood and buccal sample collection introduced for participants enrolled under (and after) Amendment #9. The sample collection deadline remains the same for TMIST participants enrolled prior to Amendment #9 — T4 screening visit for both sample types (i.e., no later than 90 days past the T4 screening visit time point). There is a grace period of 90 days after the T4 anniversary date to get the samples collected without triggering a protocol deviation.

Physics QC Program
Compliance with the TMIST Physics Quality Control (QC) Program is now easier for U.S. sites that have complied with the TMIST QC for at least one year. If your site qualifies, you will no longer have to perform weekly, monthly or annual TMIST-specific QC on your TMIST-credentialed mammography systems. The TMIST Physics QC Team has notified sites that currently qualify. If you think your site qualifies but you have not received notification, email [email protected].

COVID-19 Vaccinations and Mammography
Some patients who receive COVID-19 vaccinations may temporarily develop benign swollen lymph nodes, which can show up on mammograms and other imaging tests. Please document the timing of each COVID-19 vaccination on visit forms, if not previously reported in Rave (login required).

Site Responsibilities for TMIST After Closing to New Accruals
If your institution decides to close EA1151 to prospective enrollment, please remember your institution is still responsible for the following:

Continuing to manage all protocol assessments for subjects previously enrolled.
Maintaining IRB approval — whether NCI CIRB for U.S.-based sites or local IRB for international sites — of EA1151 throughout the entire protocol life cycle.
Meeting all future data submission requirements for subjects previously enrolled.
Submitting tissue, blood and buccal samples for women who consented.
Addressing any data management, central monitoring or audit queries.

These responsibilities remain with the enrolling institution until the study is added to the ECOG-ACRIN list of studies no longer requiring additional activities, or if all subjects are transferred to another site.

Full Study Closeout Requirements
Please note that full study closeout cannot occur at a site unless the following requirements are met:

Study has met its accrual goal or is closed for accrual at the Signatory Institution as well as at all Component and/or Affiliate Institutions relying on the Signatory Institution for this study.
All study participants have completed study interventions and follow-up activities — or — no study participants were enrolled.
No further research activity exists for this study (including recruitment, enrollment, data collection, data analysis and data submission).

Submit Pathology Materials After Breast Biopsy/Surgery
A new deadline for pathology submission has been implemented. Sites that have not submitted pathology materials for breast procedures that occurred more than six months ago should submit pathology materials (e.g., pathology reports, diagnostic pathology slides and tissue from breast biopsies/surgeries), to the ECOG-ACRIN Central Biorepository and Pathology Facility as soon as possible. Access submission instructions on the EA1151 documents portal page (CTEP IAM account required).

Remote Consent Still Allowed for TMIST
Changes were made to section 2.3.8 of the CIRB Standard Operating Procedures (SOPs) to permit the use of remote consent outside of the COVID-19 public health emergency. These changes are summarized in the Summary of Changes to the SOPs. Please contact the NCI CIRB Help Desk via email at [email protected] with any questions.