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CTRI Number  CTRI/2024/04/064991 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 28/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Screening of Oral Human Papillomavirus (HPV) 
Scientific Title of Study   Prevalence of Oral Human Papillomavirus (HPV) associated oropharyngeal squamous cell carcinoma (OSCC) among patients attending a tertiary care center in Mangalore - A prospective study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anitha J 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Manipal Institute of Virology, Room No. 111, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  08202922663  
Fax  08202922817  
Email  anitha.j@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Anitha J 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Manipal Institute of Virology, Room No. 111, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  08202922663  
Fax  08202922817  
Email  anitha.j@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Anitha J 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Manipal Institute of Virology, Room No. 111, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  08202922663  
Fax  08202922817  
Email  anitha.j@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Institute of Virology, Room No. 111, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka 
 
Primary Sponsor  
Name  Manipal Institute of Virology 
Address  Manipal Academy of Higher Education, Manipal, Karnataka 
Type of Sponsor  Research institution 
 
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 
Sreeraj S  A.J. Institute of Medical Sciences and Research Centre  A.J. Research Centre, Room No.103, A.J. Institute of Medical Sciences and Research Centre NH-66, Kuntikana, Mangaluru- 575004, Karnataka India
Dakshina Kannada
KARNATAKA 		 7042459233

sreeraj.s@ajims.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics committee - 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B977||Papillomavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Since it is an observational study the answer is Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  I. Patients above the age of 18 years with class III/IV oral cancer
II. Patients who have to undergo surgery for the removal of tumors
III. Patients complying to provide consent for the study.
 
 
ExclusionCriteria 
Details  I. Oral cancer patients not undergoing surgery for removal of tumors
II. Patients not willing to give consent for the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess the oral HPV prevalence among OSCC patients. This is crucial for devising appropriate strategies and for identifying highrisk groups that require targeted interventions.
2. Study will help in the identification of other high-risk HPV among OSCC patients.
3. The study will also explore saliva testing as a strategy for testing oral HPV among cancer population
4. The study is also aimed to identify the impact of different risk factors associated with OSCC.
5. Study will provide insights regarding mutational status of E6 and E7 oncogenes.
 		 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
4. The study is also aimed to identify the impact of different risk factors associated with OSCC.
5. Study will provide insights regarding mutational status of E6 and E7 oncogenes.
 		 12 Months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/04/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anitha.j@manipal.edu].

  6. For how long will this data be available start date provided 01-03-2025 and end date provided 28-02-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This is a prospective study that aims to determine the prevalence of different HPV genotypes in HPV associated oropharyngeal squamous cell carcinoma (OSCC). The study will be using 120 tissue biopsy and saliva samples collected from histologically confirmed OSCC positive patients from the year 2024 to 2025. The biopsy samples collected would be processed and tested by chip-based Trunat® HPV-HR kit PCR and the Truenat positive samples (HPV HR types 16/31 and 18/45) will be genotyped by conventional multiplex PCR. E6 and E7 oncogenes of HPV HR types 16 and 18 will be sequenced by Sanger sequencing and bioinformatic analysis will be performed. The Trunat® negative samples would be subjected to multiplex PCR for detecting other HR HPV. The study will help in estimating the current prevalence and burden of oral HPV in the Indian population and the impact of socioeconomic and behavioral risk factors associated with OSCC. Furthermore, study also aims to explore the use of non-invasive samples like saliva as an alternative oral HPV testing strategy among OSCC patients. 
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