NIH-funded research R01 grant

Predicting which mouth lesions may turn into oral cancer

Official title: PROSPECT: Premalignant Oral Lesions Pathology and Epigenetic Risk Prediction Tool

Funded at Loma Linda University · NIH-11124924 · Data updated 2026-11-12

This project uses noninvasive mouth samples plus AI and genetic markers to identify which premalignant mouth lesions are most likely to become oral cancer for people who have oral lesions.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionLoma Linda University
NIH-funded
Lab location1 site (Loma Linda, UNITED STATES)
Project startJuly 1, 2024
Project endJune 30, 2029
Funding year2025
Award (this year)$679,280
NIH project number5R01CA293995-02
Project IDNIH-11124924 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are people who have premalignant oral lesions (for example leukoplakia, erythroplakia, or biopsy-proven dysplasia) and are being followed or evaluated by a clinician.

Less likely to help

People without oral premalignant lesions or those who already have invasive oral cavity cancer are unlikely to benefit from this specific project.

What this research studies

You would provide simple, minimally invasive mouth cell samples and may have tissue biopsy data used when available. The team will combine large existing datasets with a new group of patients who have premalignant oral lesions and follow them over time. They will apply deep learning to cytology (cell samples), histology (tissue slides), and epigenetic (DNA-based) markers in a staged way to keep testing as simple as possible. The goal is a stepwise tool that flags high-risk lesions while sparing low-risk patients from unnecessary invasive procedures.

Why it matters

Potential benefit: If successful, the tool could help doctors spot high-risk mouth lesions earlier so those patients get prompt treatment while others avoid unnecessary biopsies and procedures.

How similar studies have gone: Previous biomarker and AI studies in oral lesions have shown promise, but this combined cytology–histology–epigenetic AI approach is novel and not yet validated in large prospective cohorts.

Where this research is happening

  • Loma Linda University
    Loma Linda, United States
    Active

Researchers

  • Principal investigator: Viet, Chi T. — Loma Linda University
  • Study coordinator: Viet, Chi T.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.