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CTRI Number  CTRI/2024/08/072789 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 08/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Is there a link between presence of specific microorganisms and the development of oral cancer?  
Scientific Title of Study   Association of Oral Microbiome Profile with Oral Squamous Cell Carcinoma 
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 Pratibha G 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Dept. of Periodontology, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448724121  
Fax    
Email  pratibha.pk@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Krishnananda Prabhu R V 
Designation  Associate Dean and Professor 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Department of Biochemistry, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal Madhava Nagar, Manipal, Karnataka State. Pin 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9844380157  
Fax    
Email  krishnananda.prabhu@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Krishnananda Prabhu R V 
Designation  Associate Dean and Professor 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Department of Biochemistry, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Madhava Nagar, Manipal, Karnataka State. Pin 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9844380157  
Fax    
Email  krishnananda.prabhu@manipal.edu  
 
Source of Monetary or Material Support  
Material support, patients - 1-Manipal College of Dental Sciences, Manipal, Karnataka - 576104 2-Kasturba Medical College, Manipal, Madhava Nagar, Manipal, Karnataka State. Pin 576104 India 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  KMC, Manipal, Manipal Academy of Higher education, Manipal, Madhava Nagar, Manipal, Karnataka State. Pin 576104 India 
Type of Sponsor  Private medical college 
 
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 Pratibha G  Manipal College of Dental Sciences, Manipal and Kasturba Medical College, Manipal, India  1)Patient recruitment and data collection - Room No. 3, Department of Periodontology, Dental clinics, MCODS, Manipal 2)Laboratory procedures - Department of Biochemistry, KMC, Manipal AND Centre for Molecular Neurosciences, Under Department of Anatomy, KMC, Manipal
Udupi
KARNATAKA 		 9448724121

pratibha.pk@manipal.edu 
 
Details of Ethics Committee
Modification(s)  
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 
Patients  (1) ICD-10 Condition: K135||Oral submucous fibrosis, (2) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  Observational study 
Comparator Agent  No agent is compared. The group for comparison will be systemically healthy patients.  Observational Case control study 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with early oral cancer, individuals with oral potentially malignant disorder (OPMD) and healthy individuals with tobacco exposure will be included. 1)Early oral cancer would comprise TNM stages 1 and 2. 2)Oral submucous fibrosis will be considered for OPMD 3)Healthy individuals with tobacco exposure will form the control group 
 
ExclusionCriteria 
Details  1. Patients on long term steroid therapy, NSAIDs or on antibiotic medication in the previous six weeks will be excluded from the study.
2. Further, those with a prior history of allergies, irradiation, chemotherapy / oncology related surgery and a history of diabetes mellitus or immune-related diseases will be excluded.
3. Pregnant and lactating women will also not be considered for the study.
4. Patients who show flu – like symptoms will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Identifying specific bacterial species showing significant variations across study groups and quantifying selected bacterial species.   36 months 
 
Secondary Outcome  
Outcome  TimePoints 
Develop a predictive model   12 months 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
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)   11/09/2024 
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="4"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - 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 - Informed Consent Form

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be made available on request to corresponding author by email 12 months following article publication

  6. For how long will this data be available start date provided 01-11-2030 and end date provided 31-01-2031?
    Response (Others) -  Beginning 12 months after article publication and ending 15 months following article publication

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This observational study aims to investigate the association between the oral microbiome and the presence of Oral Squamous Cell Carcinoma. As part of the initial work, sequencing will be carried out to analyze 12 samples (4 in each group of oral cancer, individuals with oral potentially malignant disorder, i.e., oral submucous fibrosis, and healthy individuals with tobacco exposure). Subsequently, the microbial profile of patients with oral cancer and healthy individuals will be compared in a total sample size of 216 patients. The primary outcome will be identifying bacterial species showing significant variations across study groups and quantifying selected bacterial species. Further, we intend to evaluate differences in salivary metabolites between the groups. The secondary outcome will be to develop a predictive model. 
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