NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-RTOG 1216 BIQSFP Project Title: Integral Determination of p16 Expression in Oropharyngeal Carcinoma as an Eligibility Criterion BIQSFP entire project duration: 2020 to 2025 • Total # screened/tested to date: 0; Total # planned for entire BIQSFP project: 135 (no invoices have been received to date for screening activities) • # of patients expected to be screened/tested during the reporting period: 10 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: p16; # tests expected to be completed: 6 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes If “no,” please explain. • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? o Accrual for this study has been acceptable with 60 patients expected to be enrolled in grant year 10. The need for confirmation of p16 status for the nasopharyngeal patients has not occurred at the rate originally projected and therefore less funds have been expended than originally projected. December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-BN003 BIQSFP Project Title: pHH3 Mitotic Index as an Integrated Marker BIQSFP entire project duration: 2017 to 2025 • Total # screened/tested to date: 184; Total # planned for entire BIQSFP project: 222 • # of patients expected to be screened/tested during the reporting period: 24 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: pHH3; # tests expected to be completed: 24 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? No (see below). • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? o The sample size for this trial was increased from 133 to 163 patients in a June 2022 protocol amendment due to the higher number of patients than expected withdrawing consent for treatment with RT on the trail...