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CTRI Number  CTRI/2025/07/092080 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 31/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Finding body markers to help detect oral cancer early 
Scientific Title of Study   Identification of Biomarkers for Detection of Cancer of the Oral Cavity.  
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 H Thamizhchelvan 
Designation  Dean and HOD Oral pathology and Microbiology 
Affiliation  Sri Ramachandra Institute Of Higher Education and Research 
Address  4th Floor Dental Block Sri Ramachandra Dental College 1 Ramachandra Nagar Porur Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9884105711  
Fax    
Email  hod.oralpathology@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr H Thamizhchelvan 
Designation  Dean and HOD Oral pathology and Microbiology 
Affiliation  Sri Ramachandra Institute Of Higher Education and Research 
Address  4th Floor Dental Block Sri Ramachandra Dental College 1 Ramachandra Nagar Porur Chennai


TAMIL NADU
600116
India 
Phone  9884105711  
Fax    
Email  hod.oralpathology@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr S Mythili 
Designation  Senior Lecturer of Department of Oral Pathology and Microbiology 
Affiliation  Sri Ramachandra Institute Of Higher Education and Research 
Address  4th Floor Dental Block Sri Ramachandra Dental College 1 Ramachandra Nagar Porur Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9841810304  
Fax    
Email  mythili.s@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
MedGenome Labs ltd 
 
Primary Sponsor  
Name  MedGenome Labs ltd 
Address  94/1C and 94/2 Tower1 Ground Floor Veerasandra Village Attibele Hobli Electronic City Bangalore South Karnataka India  
Type of Sponsor  Other [Genetic Testing Labs] 
 
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 H Thamizhchelvan  Sri Ramachandra Dental College and Hospital  Room 10 4thfloor Department of oral pathology and Microbiology Dental college block Sri Ramachandra Hospital 1 Ramachandra Nagar Porur Chennai
Chennai
TAMIL NADU 
09884105711

hod.oralpathology@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SRIHER   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: R888||Abnormal findings in other body fluids and substances, (2) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  An eligible patient must satisfy all of the following criteria for inclusion.
Must be 18 years or older.
Has been diagnosed with a cancer of the oral cavity by screening or clinical presentation.
Has been scheduled to undergo biopsy or surgical resection for a known or highly suspected malignancy in the oral cavity.
Shows no signs of metastasis.

Eligibility criteria for At-Risk Individuals with leukoplakia erythroplakia submucosal fibrosis oral lichen planus.
An eligible patient must satisfy all of the following criteria for inclusion.
Must be between 18 and 65 years.
Has been diagnosed with suspected OPMDs by screening or clinical presentation.
Agrees to report any changes in medical condition.
Agrees to be followed up by telephonic conversation, once every six months, for up to two years
Eligibility criteria for Apparent-Normal Individuals i.e. without any cancerous condition
An Apparent Normal volunteer must satisfy all of the following criteria for inclusion.
Must be between 18 and 65 years.
Does not present any symptoms of a cancer in the oral cavity or elsewhere.
Does not have a serious medical history or a past oral surgery.
Does not have a history of cancer in the immediate family.
Agrees to report any changes in medical condition.
Agrees to be followed up by telephonic conversation once every six months for up to two years.

 
 
ExclusionCriteria 
Details  Exclusion criteria for All cancer patients At risk and Apparent Normal Individuals
The individual is not eligible to be included in the study if he or she
Is unable to understand or willing to sign an institutional review board approved written informed consent document before any study specific procedures.
Is unwilling to comply with all study procedures.
Has any cancer other than OSCC or dysplasia in the oral cavity.
Has previously undergone an oral surgery in the past.
Has previously undergone a definitive local therapy or an extensive surgery.
Is currently undergoing or has received any chemotherapy radiotherapy or immunotherapy in the past.
Has fever or shows symptoms of a fever on the day of liquid biopsy
Is a recipient of an organ transplant or allogenic bone marrow or stem cell transplant in the past
Has undergone a blood transfusion in the last 30 days
Has been treated with corticosteroids in the last 30 days
Has a current or past pregnancy in the last 30 days.
Has a condition that, in the opinion of the clinician, would interfere with successful evaluation and interpretation of the results.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the epigenetic and proteomic alterations in participants with OCC and identify potential biomarkers  subjects Follow up will be done for every once in 6 months for 2 years for all the arm 
 
Secondary Outcome  
Outcome  TimePoints 
Development of non-invasive diagnostic products for early detection of OCC and OPMD with high sensitivity and specificity  visit for every 6 months once for 2 years 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   11/08/2025 
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="2"
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  

 

Early detection and management is an emerging paradigm to reduce cancer mortality by shifting the stage of diagnosis of most cancer types to an earlier stage  when they still might be curable  Despite the dramatic progress and development of successful therapies for cancer treatment over the past decades cancer remains the second leading cause of death globally accounting for almost one in six deaths Cancer mortality is exacerbated by late stage diagnosis especially in developing countries like India where more than two thirds of the cancer patients are already in an advanced and incurable stage at the time of diagnosis One major goal in cancer research is the detection of cancers before they metastasize to distant sites or develop drug resistance. Even when metastasis has initiated but is not yet evident radiologically cancers can be cured in up to 50 percent of cases with systemic therapies such as cytotoxic drugs and immunotherapy. Therefore earlier detection is critical for increasing the rates of survival and at significantly lower costs of treatment.

A liquid biopsy LB test primarily relies on measuring one or more circulating analytes shed by the tumour cells in the blood. These analytes include cell-free nucleic acids cfDNA or cfRNA protein biomarkers .  and other biomolecules such as glycosaminoglycans . Such tests could be supplemented with other specialized medical imaging tests such as lose dose CT or PET CT to increase the sensitivity and specificity of cancer detection at an earlier stage.

Many studies since 2016 have shown the utility of protein biomarkers evaluation of somatic mutations to identify the circulating cfDNA from tumour cells ctDNA differential fragmentation and methylation profiles of ctDNA, and presence of cancer-specific RNA species in the blood - with or without conventional radiological imaging techniques - to detect cancers before the emergence of distant metastases. Encouraged by these landmark studies, we seek to evaluate, coherently and comprehensively, many of these different next generation approaches for identification of cancer biomarkers and development of a non-invasive test for detection of oral cavity cancers (OCC and other oral potentially malignant disorders (OPMDs) to be introduced to the Indian population.

 
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