Abstract P1-01-05: Conducting Ancillary Studies during an Active NCTN/NCORP Screening Trial – The TMIST (ECOG-ACRIN EA1151) Experience
Abstract
Background: The primary aim of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) is to determine whether women randomly assigned to be screened through 3-5 rounds with tomosynthesis (TM) have fewer advanced cancers than the population screened with digital mammography (DM) over 3-8 years after entry. In addition, there are 15 secondary aims with data being collected in the areas of imaging assessment, medical physics, breast biology and pathology, long-term follow-up, and health care utilization. Women ages 45 to 74 are eligible to participate. The study will enroll 108,508 women. Participants may also volunteer to contribute blood and/or buccal smears to the TMIST biorepository. Approximately 70% of TMIST participants have agreed to do so. Because of the size of the TMIST study and vast amount of data to be collected, there is an opportunity for investigators to utilize TMIST data to support various research questions not covered in TMIST. Methods:The TMIST study team developed a process where investigators who would like access to the TMIST data can submit a concept while the trial is ongoing for access to data in a protected manner. The process starts with the project investigator reaching out to the TMIST study chair. If the study chair, lead statistician, and ECOG-ACRIN (EA) co-Principal Investigator think the project has promise; a timeline for when the project could take place (either (1) during the TMIST clinical trial or (2) after the end of the trial…
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