# NRG Oncology Network Group Operations Center

> **NIH NIH U10** · NRG ONCOLOGY FOUNDATION, INC. · 2024 · $1,106,894

## Abstract

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...

## Key facts

- **NIH application ID:** 11005623
- **Project number:** 3U10CA180868-11S1
- **Recipient organization:** NRG ONCOLOGY FOUNDATION, INC.
- **Principal Investigator:** Quynh-Thu Xuan Le
- **Activity code:** U10 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,106,894
- **Award type:** 3
- **Project period:** 2014-04-17 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11005623

## Citation

> US National Institutes of Health, RePORTER application 11005623, NRG Oncology Network Group Operations Center (3U10CA180868-11S1). Retrieved via MORVS 2026-11-02 from https://api.morvs.ai/grant/nih/11005623. Licensed CC0.

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