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CTRI Number  CTRI/2019/04/018355 [Registered on: 01/04/2019] Trial Registered Prospectively
Last Modified On: 01/04/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Single Arm Study 
Public Title of Study   Oral cancer screening study 
Scientific Title of Study   Oral Cancer Screening: Development of research partnership and feasibility study 
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Roopa Hariprasad 
Designation  Scientist-E 
Affiliation  NICPR 
Address  Room No 17, Ground floor, Division of Clinical Oncology, National Institute of Cancer Prevention and Research (NICPR), I-7, Sector, 39, Noida , Uttar Pradesh INDIA

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  01202446932  
Fax    
Email  roopaicmr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Roopa Hariprasad 
Designation  Scientist-E 
Affiliation  NICPR 
Address  Room No 17, Ground floor, Division of Clinical Oncology, National Institute of Cancer Prevention and Research (NICPR), I-7, Sector, 39, Noida , Uttar Pradesh INDIA

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  01202446932  
Fax    
Email  roopaicmr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Roopa Hariprasad 
Designation  Scientist-E 
Affiliation  NICPR 
Address  Room No 17, Ground floor, Division of Clinical Oncology, National Institute of Cancer Prevention and Research (NICPR), I-7, Sector, 39, Noida , Uttar Pradesh INDIA

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  01202446932  
Fax    
Email  roopaicmr@gmail.com  
 
Source of Monetary or Material Support  
Global Challenges Research Fund (GCRF) University of Warwick Coventry CV4 8UW UK 
 
Primary Sponsor  
Name  University of Warwick 
Address  University of Warwick Coventry CV4 8UW UK 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Roopa Hariprasad  National Institute of Cancer Prevention and Research   Room No 17, Ground floor, Division of Clinical Oncology National Institute of Cancer Prevention and Research (NICPR), I-7, Sector- 39, Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 01202446932

roopaicmr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NICPR-Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Apparently Healthy Individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Oral cancer screening  Oral visual examination 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All individuals in the age range of 30 to 65 years residing in the selected block will be examined for oral lesions. 
 
ExclusionCriteria 
Details  Individuals not permanent residents of the selected site will be excluded from the study.
Patients diagnosed with oral cancer
Individuals not giving consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Detection of oral lesions
2. Comparision of diagnosis between ASHA workers and specialist 		 One point 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="3000" 
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)   01/04/2019 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet started 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

An epidemiological transition is gathering momentum with deaths shifting from infectious diseases to non-communicable diseases (NCDs). Cancer is the second leading cause of death globally after cardiovascular disease. The prevalence of NCDs, and the resulting number of related deaths, are expected to increase in the future, particularly in India, due to population growth and ageing, in conjunction with economic transition and resulting changes in behavioural, occupational and environmental risk factors.

To achieve the Sustainable Development goal of reducing pre mature mortality due to NCD and also the National health policy 2017 which aims to reduce incidence of chronic diseases , India has started the national screening programme of common NCDs including oral, cervical and breast cancer.

The aim of this project is to develop a novel screening strategy whereby the Community Health workers will be trained to screen for oral cancers in a community based setup thereby improving primary care delivery as well.

Study design: Feasibility Study

 Study period: 6 Months

 Study population: A total of 3000 participants will be examined in Gautam Budh Nagar district of Uttar Pradesh, India. The participants will be selected conveniently.

Ethical clearance has been obtained from Institutional Ethics Committee at the National Institute of Cancer Prevention and Research (Indian Council of Medical Research).


 


 
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