FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073496 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Developing a Simple Tool to Identify People at Higher Risk of Oral Cancer Before Screening  
Scientific Title of Study   DEVELOPMENT AND VALIDATION OF A PRE-SCREENING RISK- STRATIFICATION TOOL FOR ENHANCING THE PERFORMANCE OF ORAL CANCER SCREENING STRATEGIES 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aswathi G 
Designation  PhD Research Scholar 
Affiliation  Kasturba Medical College, MAHE 
Address  Department of Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8073284025  
Fax    
Email  aswathi.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Devaraja K 
Designation  Associate Professor; Department of Head and Neck Surgery 
Affiliation  Kasturba Medical College, MAHE 
Address  Department of Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9999662597  
Fax    
Email  devaraja.k@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Aswathi G 
Designation  PhD Research Scholar 
Affiliation  Kasturba Medical College, MAHE 
Address  Department of Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8073284025  
Fax    
Email  aswathi.kmcmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Academy of Higher Education, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Aswathi G  Kasturba Medical College  Department of Head and Neck Surgery, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 8073284025

aswathi.kmcmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Oral Cancer 
Patients  (1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Case group - Patients diagnosed with oral cancer or oral potentially malignant disorder   Patient with biopsy proven oral cancer Biopsy proven or clinically diagnosed case of oral potentially malignant disorder (OPMD) Aged 18 years or above. Those with primary or recurrent malignant of oral cavity. Those who are willing to provide informed consent  
Comparator Agent  Control Group - General population without any history of oral cancer/ oral potentially malignant disorder.  A person above the age of 18 with no known case of cancer and are visiting the hospital during the study period. They could be attendants/care givers of the patient. Those with medical conditions not related to oral cancer/ OPMD, tobacco or alcohol. Those who are willing to provide informed consent  
Intervention  Model Feasibility (Phase 3)  Participants will be recruited through a house-to-house survey and from health centers, with informed consent obtained from all. Socio-demographic data and exposure patterns to tobacco/alcohol will be collected, perceptions of OraCLE will be assessed, and high-risk individuals will receive educational material and referrals for further screening and intervention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Case - control study (Phase 2):
Case Group:
Patient with biopsy proven oral cancer
Biopsy proven or clinically diagnosed case of oral potentially malignant disorder (OPMD)
Aged 18 years or above.
Those with primary or recurrent malignant of oral cavity.
Those who are willing to provide informed consent.

Control group:
A person above the age of 18 with no known case of cancer and are visiting the hospital during the study period.
They could be attendants/care givers of the patient.
Those with medical conditions not related to oral cancer/ OPMD, tobacco or alcohol.
Those who are willing to provide informed consent

Phase 3: Model feasibility study:
A person who is above 18 years of age.
Willing to provide informed
consent and information about their tobacco/alcohol habits


 
 
ExclusionCriteria 
Details  Case - control study (Phase 2):
Case group:
Patients who are critically ill, need for emergency management or admitted to the intensive care units.
Currently displaying COVID-19 related symptoms, namely a fever, cough and/or difficulty breathing or having been positively tested as infected with COVID-19 in the past 14 days.
Patients who are not willing disclose details about their tobacco/ alcohol habits.

Control group:
Patients with confirmed diagnosis of oral cancer or oral potentially malignant disorder or any kind of oral lesion.
Those with cancers other than oral cancer.
Currently displaying COVID-19 related symptoms, namely a fever, cough and/or difficulty breathing or having been positively tested as infected with COVID-19 in the past 14 days.
Patients who are not willing disclose details about their tobacco/ alcohol habits.

Phase 3: Model feasibility study:

Those who are not willing to disclose details about their tobacco/alcohol habits.
Those not willing to provide informed
consent.

 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Risk factors and their strength of association with oral cancer through a systematic review and meta- analysis (Phase 1).
Sensitivity, specificity, and predictability of OraCLE in risk stratification of oral cancer (Phase 2).
The degree of exposure to tobacco/alcohol among cases and control (Phase 2).
Feasibility and ease of applicability of OraCLE (Phase 3).
To arrive at a scientifically validated, feasible, user-friendly, and generalizable pre-screening tool for oral cancer.
 		 Phase 1: Apr 2024 - Apr 2025
Phase 2: Apr 2025 - Apr 2026
Phase 3: Apr 2026 - Apr 2027 
 
Secondary Outcome  
Outcome  TimePoints 
Feasibility and ease of applicability of OraCLE (Phase 3).  Phase 3: Apr 2026 - Apr 2027 
 
Target Sample Size   Total Sample Size="1290"
Sample Size from India="1290" 
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)   01/10/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Aim:

The primary aim of our study is to develop and validate a pre-screening model capable of stratifying risk of oral cancer based on tobacco and alcohol consumption habits, enabling the proactive identification of individuals at an elevated risk of developing oral cancer.

Objectives:

·       To assess the risk factors and estimate their strength of association with oral cancer through synthesis of existing evidence from literature (Phase 1).

·       To refine the existing risk stratification tool (OraCLE) with the results obtained from the systematic review and meta-analysis (Phase 1).

·       To validate OraCLE (Oral Cancer Likelihood Evaluator) in a hospital setting through a case- control study design (Phase 2).

·       To evaluate the ease of applicability and feasibility of implementing the model in a community setting (Phase 3).

Justification for study:

·       Evidence from several studies indicate that most oral cancers are detected in the later stages leading to poor prognosis and low treatment outcomes. The only way to overcome this is by implementing continuous screening processes at high-risk regions.

·       The major factor hindering the performance of oral cancer screening program is the process of selection of right target population. Although studies focus on all those who abuse tobacco/ alcohol, they fail to incorporate demographic profile and the degree of exposure to these carcinogens for an individual.

·       This emphasizes the need for a risk stratification tool like OraCLE that can categorize risk profiles of individuals exposed to carcinogens and also work as a pre-screening tool enabling selection of high-risk individuals for subsequent screening program.

·       OraCLE will not only be simple to implement but will also be resource-efficient considering the concerns of cost and accessibility of current screening programs.

·       Applying OraCLE as a pre-screening model at various regional and national level health centres, especially in the LMIC region can enable timely detection of the disease and also aid in bridging

the gap between disease identification and treatment, thereby curbing the oral cancer burden in the society.

 Detailed description of procedure / processes:

Phase 1: Systematic review and meta-analysis:

·       To develop a comprehensive systematic review protocol and register the protocol in PROSPERO prior to initiation of search strategy.

·       To assess the risk factors and estimate their strength of association with oral cancer through synthesis of existing evidence from literature.

·       The risk factors with the highest strength of association shall be considered for incorporation in OraCLE.

·       To arrive at a refined version of OraCLE in this phase.

Phase 2:

·       Study participants shall be recruited and categorized as cases or controls based on the inclusion and exclusion criteria after obtaining the signed informed consent at their own will.

·       For each case, three controls shall be selected and will be age group (±5 years) and gender matched.

·       A pre-designed proforma shall be used to collect data about the subject’s demographics, socio- economic status, cancer history and exposure pattern to tobacco/alcohol. The history of oral cancer (applicable only to cases) will be extracted from medical records while rest of the data shall be collected through a brief interaction with the patient. The interaction will be quick and will take place during the patient’s waiting time in the OPD.

·       Interaction with the study subjects will be a one-time event as the study doesn’t require any follow-ups.

·       OraCLE shall be used to stratify the subjects as low, moderate, or high risk. Phase 3:

·       Study participants shall be recruited from the community through a house-to-house survey to check the tool’s feasibility. Health workers in the health centers shall also be included in the study.

·       Informed consent shall be obtained from all the study participants.

·       The recruited subjects shall be interviewed to collect their socio-demographic details and exposure patterns to tobacco/alcohol. The collected data shall be recorded in a pre-designed proforma.

·       A simple questionnaire shall be administered to assess the individual’s and health worker’s perception and acceptability of OraCLE.

·       The moderate and high-risk individuals recognized through the house-to-house survey will be provided with educational material (pictorial and written material in local language) about the ill-effects of tobacco and alcohol and about the behaviour modification strategies against use of tobacco/ alcohol. This will enable sensitizing the study population regarding harmful effects of tobacco and development of oral cancer. The individuals will also be directed towards a community health centre for further screening and intervention.

  Sample size: Phase 1: All the eligible articles exploring the risk factors of oral cancer will be included for systematic review and meta-analysis.

Phase 2: Sample size is based on prediction ability of binary classifier model. The prediction ability is measured using area under ROC Curve (0-1 with 1 being good prediction ability).

Assuming area under ROC curve to be 0.85, based on literature (Amarasinghe et al., 2010) with 5% precision, the sample size needed in each group (cases and controls) is 130.

To increase the power of the study, the ratio of cases: control shall be taken as 1:3. Total sample size: 130 cases and 390 controls = 520 subjects.

 

Phase 3:     Sample size (n) is estimated based on the formula below:

n = (z)2 p (1 – p) / d2 where,

z = 95% level of confidence (1.96)

p = Estimated proportion of the population that presents the characteristic (0.5) d = Tolerated margin of error (5%)

Using the formula above, we arrived at a sample size of 385.

Total sample size = 385 * 2 (Adjusting for design effect of 2) = 770. Number of health centers = 4

Sample size for each health center = 770/4 = 193.

193 general population from each health center attached to the Department of Community medicine, KMC, Manipal shall be recruited. The feasibility of OraCLE shall be evaluated in this phase by implementing the tool in the community, among the general population. Additionally, the health workers from the health centers will be eligible to participate in the study to check for the tool’s acceptability.

 

 Outcome measures:

The outcome measures in this study will be:

·       Risk factors and their strength of association with oral cancer (Phase 1).

·       Sensitivity, specificity, and predictability of OraCLE in risk stratification of oral cancer (Phase 2).

·       The degree of exposure to tobacco/alcohol among cases and control (Phase 2).

·       Feasibility and ease of applicability of OraCLE (Phase 3).

·       To arrive at a scientifically validated, feasible, user-friendly, and generalizable pre-screening tool for oral cancer.

 
Close