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CTRI Number  CTRI/2021/06/034010 [Registered on: 04/06/2021] Trial Registered Prospectively
Last Modified On: 02/06/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of precancerous lesions and its associated factors in Manipur 
Scientific Title of Study   Prevalence of oral premalignant lesions (OPML) and its associated factors in north east indian population with special reference to state of Manipur 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tanya Nandkeoliar 
Designation  Assistant Professor 
Affiliation  Regional institute of medical sciences (RIMS) 
Address  Dental college,room no 3 regional institute of medical sciences (RIMS) lamphelpat imphal

Imphal West
MANIPUR
795004
India 
Phone  9891725253  
Fax    
Email  tanya.nandkeoliar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrChAnupriya 
Designation  Research Assistant 
Affiliation  Regional institute of medical sciences (RIMS) 
Address  Dental college,room no 3 regional institute of medical sciences (RIMS) lamphelpat imphal

Imphal West
MANIPUR
795004
India 
Phone  8731816543  
Fax    
Email  anupriya3390@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrChAnupriya 
Designation  Research Assistant 
Affiliation  Regional institute of medical sciences (RIMS) 
Address  Dental college,room no 3 regional institute of medical sciences (RIMS) lamphelpat imphal

Imphal West
MANIPUR
795004
India 
Phone  8731816543  
Fax    
Email  anupriya3390@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
dental collegeRegional institute of Medical sciences  Dental college,Regional institute of medical sciences,lamphelpat imphal 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tanya Nandkeoliar  Dental College Regional Institute of Medical Sciences (RIMS)  Room no 1, Department of Oral Medicine and Radiology and Room no 3, Department of Periodontology
Imphal West
MANIPUR 		 9891725253

tanya.nandkeoliar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH ETHICS BOARD(REB)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  INDIVIDUALS WITH SIGNS AND SYMPTOMS OF ORAL PREMALIGNANT LESIONS AND CONDITIONS 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)individuals residing in Manipur for more than 6months
2)individuals who have the history of tobacco usage, denture wearers or any other irritational factors and/or having signs and symptoms of oral premalignantlesions 
 
ExclusionCriteria 
Details  1)Individuals less than 18yrs of age
2)Migratory population with not more than 6 months of residence in Manipur
3)Individuals not having history of tobacco usage ,denture wearers,or any other irritational factors
4)Individuals having no sings and symptoms of oral premalignant lesions. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
the present study is expected to show high prevalence of oral premalignant lesions and conditions .  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
the study may predict the incidence of oral cancers in Manipur  2 years 
 
Target Sample Size   Total Sample Size="2800"
Sample Size from India="2800" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/06/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be made available after completion of study ,compilation of results and publication.

  6. For how long will this data be available start date provided 20-08-2022 and end date provided 22-08-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

A)Background Globally oral cancer is one of the most common cancers and are preceded by oral pre-malignant lesions and conditions such as oral leukoplakia, oral submucous fibrosis (OSMF),and oral erythroplakia which can be easily detected by visual inspection or palpation by health care professionals

 

B)Novelty The proposed study on Oral Premalignant Lesions and conditions would be the first of its kind in the northeast part of India.There is a high rate of mortality and morbidity among individuals and hence it requires to be detected in the premalignant stage to prevent deaths.

 

  C)Objectives

          1. To estimate the prevalence of oral premalignant lesions.

         2. To identify the probable risk factors associated with oral premalignant lesions

         3.To suggest preventive measures for oral cancers by early identification of oral premalignant lesions.

2.            4. To prevent malignant transformation of these cases by early detection and to counsel the detected cases for pursuing early treatment.

3.            5.To address the north eastern community for awareness and prevention of cancer through this study.

D)Methods:

The present study will include case and control group. Individual having history of tobacco usage, denture wearers or any other irritational factors such as malposed teeth impinging on the mucosa and/or having signs and symptoms of OPML and conditions would be included in the case group while those presenting with no signs of OPML  and conditions but having the history of tobacco usage, denture wearers, or any other irritational factor, etc would constitute to control group. All individuals will be subjected to a questionnaire and the oralcavity of these participants will be examined. Individuals belonging to the case group would then  be subjected to vital staining using toluidine blue dye and biopsy followed by histopathological examination. The data obtained will be subjected to statistical analysis.

   E) Expected outcome: The present study is expected to show high prevalence of oralpremalignant lesions and hence can be used to predict the incidence of oral cancers.

   F)Keywords: Oral Premalignant Lesions, Oral Premalignant Conditions, Leukoplakia, Oral Submucous Fibrosis, Tobacco use

   G)Abbreviations: OPML= Oral Premalignant Lesions, OSMF= Oral Submucous Fibrosis





 





 
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