# Optimization of anal cancer screening for people with HIV using genomic methods

> **NIH NIH K08** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2024 · $187,148

## Abstract

PROJECT SUMMARY
Anal cancer represents approximately ~10% of all solid cancers among people with HIV (PWH) and is
responsible for ~4% of all mortality in this group, representing a major morbidity burden in this population.
Screening for anal precancerous lesions and treating these tumors has been proven to prevent invasive cancer
and offers a clinical opportunity for addressing this emerging disease. However, standard screening tests (anal
cytology and high-risk HPV testing) have very poor specificity leading to burdensome and invasive
confirmatory testing. To address this we have identified genomic alterations that can identify anal high-grade
squamous intraepithelial lesions (aHSIL), the immediate precursors of invasive cancer, with potentially greater
accuracy and at lower cost than standard screening tests. However, the application of this approach for
screening has not yet been investigated. The Specific Aims of this research proposal are (1) to compare the
performance of a cytobrush-based, novel genomic test for the detection of aHSIL, to standard of care in a
prospective cohort of people with HIV (PWH) at high risk of anal cancer and (2) to identify genomic alterations
associated with aggressive aHSIL lesions and to develop a classifier the predicts lesions that are more likely to
recur. To address these Aims, we will enroll a prospective cohort of 250 PWH for anal cancer screening and
longitudinal data collection. This project will validate a genomic panel to identify aHSIL and compare it to
standard of care screening as well as identify biomarkers associate with aHSIL recurrence. This application will
also support Dr. Richard Silvera's career development into an independent patient-oriented investigator in the
field of anal cancer among people with HIV. Dr. Silvera's career goal is to become a leader in developing novel
strategies for the identification and prevention of anal cancers among PWH. The proposed career development
plan integrates in-depth mentoring from a team of senior scientists and clinicians, advanced coursework in
research design, analysis, cancer genomics, biomarker development, and experiential learning through the
conduct of the proposed research in a highly supportive environment. The mentorship team, which includes
independent investigators with extensive expertise in research of cancers among people with HIV as well as
the genomics of cancer, will guide the candidate's research and career development. At conclusion of this
project Dr. Silvera will be well positioned to become an independent physician-investigator studying biological
and clinical issues related to anal cancers among people with HIV.

## Key facts

- **NIH application ID:** 10785779
- **Project number:** 1K08CA285939-01
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** Richard Silvera
- **Activity code:** K08 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $187,148
- **Award type:** 1
- **Project period:** 2024-09-01 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10785779

## Citation

> US National Institutes of Health, RePORTER application 10785779, Optimization of anal cancer screening for people with HIV using genomic methods (1K08CA285939-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10785779. Licensed CC0.

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