| 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
|
|
|
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
|
|
|
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
|
|
|
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. |