JMIR Publications

ABSTRACT

Background:

Oral potentially malignant disorders (OPMDs) constitute the most important precursors of oral cancer, tobacco being the common risk factor for both these conditions. Histopathological examination of a biopsy from a clinically suspicious lesion is still the gold standard for diagnosis of oral cancer. Adjunctive techniques such as autofluorescence, toluidine blue, and others have been evaluated among high-risk individuals such as chronic tobacco chewers or in patients presenting with clinically suspected lesions. However, evaluation of these non-invasive adjunctive techniques has not been performed in field settings with primary healthcare providers. Considering that the first point-of-contact of individuals living in rural and semi-urban areas are the healthcare workers in primary health centers, evaluation of these non-invasive adjuncts is likely to assist, enhance, and strengthen the population-wide oral cancer screening efforts in high-burden countries such as India.

Objective:

This ongoing study aims to evaluate the non-invasive adjuncts in oral cancer screening in the field settings, specifically in detecting foci of oral cancers in various OPMDs.

Methods:

We shall be conducting oral cancer screening camps in the community and individuals with OPMDs shall be recruited in the study after informed consent. All patients with OPMD shall undergo further screening by autofluorescence (AF) and toluidine blue (TB) staining for detection of lesions suspicious of development of oral cancer. The gold standard for oral cancer detection shall be histopathological examination of a biopsy from the suspected lesions. Sensitivity, specificity, and negative and positive predictive values of these adjunctive techniques (AF, TB) in detection of oral cancer shall be calculated. Additionally, this study will also focus on the development and validation of risk-based stratification and appropriate medical and/ or surgical management protocols for the OPMDs at the primary and referral healthcare centers. A predesigned proforma shall be utilized for risk stratification and the 2022 consensus guidelines on management of OPMDs shall be evaluated for implementation in the existing healthcare system. Our primary outcome is the diagnostic utility of AF and TB in oral cancer detection among OPMDs as well as the robustness of the risk-based management protocols for these patients.

Results:

Subject recruitment has been initiated at all sites. The study results shall be published in peer-reviewed indexed scientific journal and presented at national and international conferences.

Conclusions:

The results of this study shall provide robust evidence on the diagnostic utility of autofluorescence and toluidine blue in early oral cancer detection among OPMD patients. Use of these non-invasive adjuncts by the primary healthcare providers can significantly improve oral cancer screening at the community level in our country. The validation of risk-based stratification and management of OPMD patients shall assist in refinement of the national/ regional guidelines for these interventions. This study has been approved by the Institute Ethics Committee of ICMR-National Institute of Cancer Prevention and Research and the respective Ethics Committee of the collaborating institutes. The findings of this study shall be disseminated through scientific publications in peer-reviewed journals as well as meetings with the concerned stakeholders at the district and state health departments.