A study of oral mucosal examination incorporating direct fluorescence visualization (FV) on the early detection of malignant lesions and lesions with malignant potential in a community, ambulatory setting in India.

 Purpose

To provide oral mucosal cancer screening to underserved communities in India and to collect information about participants’ risk factors, and oral cancer awareness. This information will assist us in planning further oral mucosal cancer screening programs in the community and to develop and tailor information and educational resources for each respective community.

Study Justification

Oral cancer is an important global health problem.  More than 300,000 cases are diagnosed annually.[1] This disease has a high mortality rate (~50% 5-year survival) mainly due to the advanced stage at which it is diagnosed.[2]  Oral cancer screening can be effective in identifying treatable disease at an earlier stage. In a study from India, trained health care workers were taught to screen for oral cancer. Screening resulted in a 24% reduction in mortality in people with high-risk habits compared to those who did not receive screening.[3]

Oral cancer screening examination

Oral cavity screening is a quick, painless, and non-invasive exam. Its intent is to identify suspicious lesions for further analysis. Studies from India show a low proportion of people utilize dental care; in a study by Pradeet et al, only 21% of people surveyed accessed dental care.[11]  It has been estimated that 37,000 lives could be saved annually as a result of oral cancer screening.[12]

Fluorescence visualization (FV)

            An FV examination is conducted with a device (Velscopeâ„¢) that emits light with filters that block all visible light except for blue light. FV allows for the direct comparison of both abnormal and normal tissue within the same field of view, allowing the clinician to subjectively evaluate changes in regards to other tissue [15] and to capture the result via camera.  

Objectives

Feasibility Study Phase

1.      To assess the feasibility practicality compliance and satisfaction of community based oral cancer screening.

2.      Identify other service delivery service needs To assess the ability to acquire high quality visual images and tissue biopsies samples on the study cohort as per protocol. 

3.      To identify oral mucosal lesions requiring biopsy through a screening examination augmented by FV. Lesions will be categorized as either negative with known cause no clinical concerns or positive clinically suspect cancer or precancer.

Research Method

Schedule of Events

Study Group

Participants will be recruited from community. Social workers will visit the target communities prior to the study to raise awareness of oral cancer.

Participants will be asked if they would like to receive a free oral cancer examination. If they agree, informed consent will be carried out by study volunteers overseen by a study investigator.

Feasibility Study Phase: A minimum of 100 participants will be screened over 1-2 days of screening. One hundred participants will provide the research team with sufficient experience to assess the study protocol, CRFs, and issues such as patient flow, participants and lesion assessment, and management to fine tune the cohort study.

Inclusion Criteria

1.      Age ≥18 years.

2.      Ability to understand and the willingness to sign a written informed consent document.

            Exclusion Criteria

1.      Unwilling to provide consent.

2.      Prior history of oral cancer

3.      Concomitant physical or mental disability precluding ability to comply with study  protocol requirements

4.      Suspected/confirmed infectious diseases/conditions.

Study Desig- Feasibility Study Phase

This study is a single arm study with consecutive accrual to the trial cohort. No comparison cohort will be accrued. This feasibility study phase will assess our ability to register, acquire information (data and images), and to conduct clinical and fluorescence visualization exams of the oral cavity in the community setting.

1.      References

[1] Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015;65:87-108. 10.3322/caac.21262.

[2] Canadian Cancer Society, Statistics Canada, Public Health Agency of Canada. Canadian Cancer Statistics 2014. Toronto2014.

[3] Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Thomas G, Anju G, et al. Long term effect of visual screening on oral cancer incidence and mortality in a randomized trial in Kerala, India. Oral Oncol. 2013;49:314-21. 10.1016/j.oraloncology.2012.11.004.

[4] Chaturvedi AK, Anderson WF, Lortet-Tieulent J, Curado MP, Ferlay J, Franceschi S, et al. Worldwide Trends in Incidence Rates for Oral Cavity and Oropharyngeal Cancers. J Clin Oncol. 2013. 10.1200/JCO.2013.50.3870.

[5] Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005;55:74-108.

[6] Warnakulasuriya S. Global epidemiology of oral and oropharyngeal cancer. Oral Oncol. 2009;45:309-16. 10.1016/j.oraloncology.2008.06.002.

[7] Dikshit R, Gupta PC, Ramasundarahettige C, Gajalakshmi V, Aleksandrowicz L, Badwe R, et al. Cancer mortality in India: a nationally representative survey. Lancet. 2012;379:1807-16. 10.1016/s0140-6736(12)60358-4.

[8] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66:7-30. 10.3322/caac.21332.

[9] Dandekar M, Tuljapurkar V, Dhar H, Panwar A, AK DC. Head and neck cancers in India. J Surg Oncol. 2017;115:555-63. 10.1002/jso.24545.

[10] Canadian Academy of Health Sciences. Improving access to oral health care for vulnerable people living in Canada. Ottawa, Ontario.2014.

[11] Pradeep Y, Chakravarty KK, Simhadri K, Ghenam A, Naidu GM, Vundavalli S. Gaps in need, demand, and effective demand for dental care utilization among residents of Krishna district, Andhra Pradesh, India. J Int Soc Prev Community Dent. 2016;6:S116-21. 10.4103/2231-0762.189737.

[12] Sankaranarayanan R, Ramadas K, Thomas G, Muwonge R, Thara S, Mathew B, et al. Effect of screening on oral cancer mortality in Kerala, India:  A cluster-randomized controlled trial. Lancet. 2005;365:1927-33. Doi 10.1016/S0140-6736(05)66658-5.

[13] Richards-Kortum R, Sevick-Muraca E. Quantitative optical spectroscopy for tissue diagnosis. Annu Rev Phys Chem. 1996;47:555-606.

[14] Richards-Kortum R, Drezek R, Sokolov K, Pavlova I, Follen M. Survey of Endogenous Biological Fluorophores. In: Mycek M, Pogue B, editors. Handbook of Biomedical Fluorescence. New York: Dekker; 2003. p. 237-64.

[15] Lane P. Fluorescence Instrumentation for the Direct Visualization of Oral Mucosa. In: Kugel G, editor. The Inside Summit on Oral Cancer Discovery and Management:  The Technologies and the Role of Dental Clinicians. Boston2007. p. 15-8.