Risk for Oral Cancer Study (ROCS)
This pilot study evaluated feasibility and acceptance by patients and dental providers of oral HPV detection in the National Dental Practice-Based Research Network. The study was conducted in two parts. Through a secure tablet-based web application patients were screened, consented and completed baseline questionnaires (Part 1). Based on survey responses, the top three deciles of risk and a random selection of 1 in 12 of those in the lower deciles were selected for an oral rinse for human papillomavirus (HPV) detection. Samples were obtained and shipped to a central laboratory by qualified practice staff. The central lab communicated results to the dental practitioner through the study’s secure web application. Patients with a high-risk oral HPV infection were offered enrollment into a prospective study (Part II) inclusive of an oral cancer examination, and a 6-month follow-up dental visit (window: 5-9 months) with a repeat oral rinse and an electronic oral cancer risk factor survey. The pilot study was a 6-month longitudinal study (window: 5-9 months). However, the study was cross-sectional with a single visit for the overwhelming majority (99.9%) of participating patients.
- Electronic Study Summary, Part I Oral HPV Screening (Appendix A).
- Oral HPV Risk Factor survey (Appendix C)
- HNS providers completed a ROCS Oral Cancer Screening Examination Form
- Part II patients completed the Oral Cancer Risk Factor survey (Appendix J)
- ROCS Provider Survey (Appendix P) upon completion of all study procedures.