To develop a Risk Factor scoring system and Registry for Oral Precancers

Not yet recruiting

Conditions: Dental diseases
Other general symptoms and signs,

Registration Number: CTRI/2020/07/026921

Lead Sponsor: No sponsor Non funded study

Brief Summary: **Introduction:**Oral cancer is preceded by Oral Potentially Malignant disorders (OPMDs) in 60-80 % of the cases but the national oral cancer screening programs are focused only on early detection and down staging of oral cancer rather than early detection and prevention of OPMDs.The national cancer registries do not record the clinicopathological details of underlying OPMDs in cases of Oral Cancer. A comprehensive oral cancer control program should also focus on OPMDs but there are no regional / population based registries for the same.OPMDs like Oral Submucous Fibrosis are typically associated with smokeless forms of tobacco and betel nut and are more common in the Indian population which is different from OPMDs seen in the western countries where smoking tobacco is more common.Only small hospital- based and few community -based studies related to OPMDs are available from India and they report higher malignant transformation rates for OPMDs in Indian patients as compared to western studies. The diagnosis management and follow up of these lesions are also not standardized as there are no universal guidelines or protocols that can be adapted within the Indian context.Hence a systematic approach like developing a registry for OPMDs, which will capture demographics, risk profile, management outcomes, and malignant transformation rates is required. The template can be replicated in other tertiary care centers and can contribute to formation of a national registry for OPMDs. Hence a longitudinal prospective study has been designed to determine the epidemiology, risk factors, diagnosis, management outcomes and malignant transformation rates in OPMDs.

**Primary** **Objective:**

To develop a risk factor scoring system and template for a registry for Oral Potentially Malignant Disorders

**Secondary objectives**:

To determine the distribution of demographics, risk factors and clinical features among various Oral Potentially malignant Disorders.

To determine the outcomes of non- invasive diagnostic adjuncts and various interventional measures in the management of Oral potentially malignant Disorders

To determine the factors for malignant transformation in Oral Potentially Malignant Disorders

**Methodology:**

Study design : Longitudinal Observational cohort study

Number of Patients:All consecutive patients with OPMD registered in the Oral Medicine & Radiology clinic and Oral Ulcer special clinic

This registry will be based in the OPD of Oral Medicine & Radiology (OMR) Division at CDER AIIMS. All patients reporting to the OPD will undergo opportunistic screening for Oral Potentially Malignant Disorders (OPMDs) and Oral cancer. The Junior and Senior residents working in the OPD will be trained in the screening process as per national guidelines which will include enquiry about demographics, risk factors for OPMDs and Oral cancer including history of tobacco betel nut and alcohol and performing Oral visual examination and palpation. They will also follow the national guidelines for behavioral and pharmacological counseling for Tobacco, Betel nut and alcohol cessation. Addiction Scales for smoking / smokeless tobacco, betel quid and alcohol will be recorded at each follow â€“up to see the quit rate amongst the OPMD subjects. Photographic records of lesions will be kept and shared with the patient to improve understanding and evolution of the nature and site of the lesions. Mouth self- examination technique will be demonstrated via video or chart to improve patient adherence to follow- up protocol and reporting earlier if there is any worsening of lesion/ condition. All patients identified with OPMDs will then undergo further examination and investigations for confirmation of diagnosis and the details will be recorded in a proforma that will be developed for the registry. These would include biopsy with/ without adjuncts like vital staining/ autofluorescence. The WHO mucositis score , VAS scores, mouth opening measurements, addiction status Fagerstrom test, AUDIT, BQDS scale and OHIP-14 will be assessed at baseline and subsequent follow-ups.All known risk factors like age, sex site type, family history of cancer, previous history of cancer, tobacco/ alcohol/ betel nut habits, histopathology, immunosuppression, HPV positivity will be recorded and risk factor scoring system developed according to malignant transformation rates seen in different OPMDs. Since the risk for malignant transformation in various OPMDs is lifeâ€“long, the subjects will be kept under regular surveillance 1/3 months review in the first two years and biannual/ annual review thereafter depending on the type and severity of the OPMD. Telemedicine may also be used for follow- up of patients who are not able to come for follow up, as the facility is evolving in AIIMS

**Statistical analysis:**

Descriptive statistics will be used to summarize the data on a yearly basis and every 5 years to determine the trends in the registration of different types of OPMDs. Comparative analysis between different groups OPMDs will be done for age, sex, habit history, status and addiction levels, oral symptoms and histopathological criteria. Comparative analysis will be done for different clinical, histological types and results of adjunctive diagnostic aids ( stains/ autofluorescence) within the same group of OPMD for response to interventions, follow up and malignant transformation . Multinomial regression analyses will be done to determine the odds for malignant transformation in different types and groups of OPMDS for various risk factors as compared to the control group. A scoring system will be developed according to risk factors to help predict malignant transformation

**Expected Outcomes:**

A registry for OPMDs will help to capture the real incidence, prevalence, risk factors, malignant transformation rates of these lesions. The diagnosis, risk factor analysis and scoring, management and follow up of these lesions will also be standardized as there are no universal guidelines or protocols that can be adapted within the Indian context. The early identification of risk factors, diagnosis and management of these OPMDs will eventually help in the prevention, early diagnosis and down staging, reducing mortality and improving prognosis in oral cancer. After successful implementation of this hospital- based registry in CDER it can then be extended for use in other tertiary care hospitals in the country and ultimately be linked/ integrated to national oral cancer registry and GIS and help in further refinement of government policies and programs for success of national population- based Oral cancer screening program. The format of the registry can also be used by other South East Asian countries who share the same menace related to OPMDs and Oral cancer as India

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Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 5000

Inclusion Criteria

Patients All consecutive patients with clinical diagnosis of any type of Oral Potentially Malignant Disorder Control(s) Subjects with habit of tobacco , betel nut or alcohol in any form but no Oral Potentially Malignant Disorder or oral cancer.

Exclusion Criteria

Subjects not willing to participate in the study.
Subjects with any oral lesion other than OPMD (traumatic, allergic, viral, chronic auto -immune, bacterial, deep fungal, nutritional deficiencies, etc.) Subjects with current or past history of oral cancer.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A hospital based registry of Oral Potentially Malignant Disorders	At the end of completing 5 years of this study
A risk factor scoring system for predicting malignant transformation in Oral Potentially Malignant Disorders in Indian patients	At the end of completing 5 years of this study

Secondary Outcome Measures

Name	Time	Method
Standardized protocol for diagnosis, management and follow up for Oral Potentially Malignant Disorders in Indian patients	At the end of completing 5 years of this study

Trial Locations

Locations (1): All India Institute of Medical Sciences New Delhi
🇮🇳
West, DELHI, India
All India Institute of Medical Sciences New Delhi
🇮🇳West, DELHI, India
Dr Shalini Gupta
Principal investigator
9971904592
shalinigupta@hotmail.com