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CTRI Number  CTRI/2025/03/081968 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   An observational study on mouth microorganisms of healthy participants and oral cancer patients to understand key differences among them and to decipher the role of mouth microorganisms in progression of oral cancer. 
Scientific Title of Study   Understanding the Interplay of Oral Microbiome in Progression of Oral Squamous Cell Carcinoma 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IEC1:552/2024  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharath Prasad A S 
Designation  Assistant Professor 
Affiliation  Manipal School of Life Sciences 
Address  Ground Floor, Department of Public Health Genomics, Annex Building, Manipal School of Life Sciences, MAHE Planetarium Complex, Manipal Udupi, Karnataka - 576104

Udupi
KARNATAKA
576104
India 
Phone  9844550116  
Fax    
Email  bharath.prasad@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharath Prasad A S 
Designation  Assistant Professor 
Affiliation  Manipal School of Life Sciences 
Address  Ground Floor, Department of Public Health Genomics, Annex Building, Manipal School of Life Sciences, MAHE Planetarium Complex, Manipal Udupi, Karnataka - 576104

Udupi
KARNATAKA
576104
India 
Phone  9844550116  
Fax    
Email  bharath.prasad@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Bharath Prasad A S 
Designation  Assistant Professor 
Affiliation  Manipal School of Life Sciences 
Address  Ground Floor, Department of Public Health Genomics, Annex Building, Manipal School of Life Sciences, MAHE Planetarium Complex, Manipal Udupi, Karnataka - 576104

Udupi
KARNATAKA
576104
India 
Phone  9844550116  
Fax    
Email  bharath.prasad@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education, Manipal University Building, Madhava Nagara, Manipal, Udupi, Karnataka, India - 576 104. 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  University Building, Madhava Nagara, Manipal, Udupi, Karnataka, India - 576 104. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Manipal Centre for Biotherapeutics Research  MCBR, Manipal 576104 
Manipal College of Dental Sciences  MCODS, Manipal - 576104 
Manipal College of Pharmaceutical Sciences  MCOPS, Manipal 576104 
Manipal Institute of Technology  MIT, Manipal 576104 
Manipal School of Life Sciences  MSLS, Planetarium Complex, Manipal, Udupi- 576104 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Adarsh Kudva  Manipal College of Dental Sciences  Ground Floor, Department of Oral and Maxillofacial Surgery, MCODS, Madhav Nagar, Manipal -576104.
Udupi
KARNATAKA 		 9886245099

adarsh.kudva@manipal.edu 
Dr Bharath Prasad A S  Manipal School of Life Sciences  Department of Public Health Genomics, Manipal School of Life Sciences, Planetarium Complex, Manipal, Udupi- 576104
Udupi
KARNATAKA 		 9844550116

bharath.prasad@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  Any subject of age 18 or more than 18 years, irrespective of sex who has not been diagnosed with Oral Squamous Cell Carcinoma or any other related cancer conditions. 
Patients  (1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. The person (irrespective of sex) should have been diagnosed with Oral Squamous Cell
Carcinoma.
2. Pre-malignant stages (ulcers, early lesions) and early malignant stages (T1 and T2) cases will
be considered for the study.
3. Patients with and without tobacco chewing, areca nut chewing, smoking, and alcohol
consumption will be considered for the study. 
 
ExclusionCriteria 
Details  1. Individuals who are less than 18 years of age.
2. Patients diagnosed with late stages of OSCC (T3 and T4).
3. Patients characterized with highly malignant and metastatic OSCC with signs of excessive tumour outgrowth leading to the opening of mouth and trismus. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is the analysis of microbiome composition, including bacterial diversity, dysbiosis patterns, and microbial taxa distribution. This will be assessed by comparing microbiome profiles among healthy individuals, individuals with premalignant conditions, and patients diagnosed with oral squamous cell carcinoma (OSCC).  All outcomes will be assessed at a single time point, specifically at baseline, upon sample collection from cases and controls. Since this is a case-control study, no follow-up assessments will be conducted, and microbiome analysis will be based on retrospective comparison between study groups. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes include comprehending the Dysbiosis Index to quantify microbial imbalance across the study groups and the identification of specific microbial taxa that may be associated with the progression from a non-cancerous state to OSCC.  Single time point at baseline (upon sample collection) 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   01/04/2025 
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)
Modification(s)  		 Open to Recruitment 
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 -  Study Protocol
    Response -  Statistical Analysis Plan

  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 - Proposals should be directed to [bharath.prasad@manipal.edu].

  6. For how long will this data be available start date provided 01-04-2025 and end date provided 31-01-2028?
    Response - Immediately following publication. No end date.

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

Background and Rationale: OSCC is one of the significant public health challenges, particularly in countries like India, where the prevalence of the disease is high, supposedly due to lifestyle and environmental risk factors. Even though there are advancements in diagnostics and treatment in current times, the survival rates for patients with OSCC are relatively low, mainly because of diagnosis at the advanced stages and a lack of deeper understanding into early disease mechanisms. Recent studies have paved the way for interlinking oral cancer with the microbiome of the oral cavity, yet the specific interplay between the oral microbiome and OSCC progression remains poorly understood. This study aims to bridge this critical research gap on longitudinal analyses of microbiome shifts from premalignant conditions to OSCC. The findings could enhance our understanding of pathogenesis in OSCC, aiding the development of microbial biomarkers for early detection and prognostics of OSCC. In the future, these findings could also implicate the development of novel microbiome-targeted therapeutic interventions to control and combat OSCC.

AIM

To investigate the role of the oral microbiome in the progression and development of oral squamous cell carcinoma (OSCC) by studying the microbiome shifts over time in patients at different stages of OSCC progression.

Objectives:

1.     To characterize the composition and diversity of the oral microbiome in OSCC patients compared to healthy controls.

2.     To investigate changes in the oral microbiome during disease progression from premalignant lesions to early malignant OSCC.

3.     To correlate specific microbial genera and dysbiosis associated with clinical and pathological features of OSCC.

4.     To identify potential microbial biomarkers for early diagnosis and prognosis of OSCC based on microbial signatures.

Hypothesis: The composition and dynamics of the oral microbiome are associated with the development and progression of OSCC through the modulation of inflammatory mechanisms and the tumor microenvironment. 


 
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