| CTRI Number |
CTRI/2025/07/090660 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Early detection of oral cancer using non-invasive salivary test |
|
Scientific Title of Study
|
Evaluating the role of salivary miRNA 372 and 486-3p as diagnostic biomarkers in Oral Squamous Cell Carcinoma, precancerous lesions and healthy individuals using qRT-PCR. |
| 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.M.Parasakthi |
| Designation |
Research Scholar |
| Affiliation |
SRM Dental College |
| Address |
Dr.M.Parasakthi
Dept. of Oral Pathology
Main block
Fifth floor
SRM Dental College
Bharathi Salai
Ramapuram
Chennai- 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9080998691 |
| Fax |
|
| Email |
dr.parasakthi2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavitha Sanjeev |
| Designation |
Professor |
| Affiliation |
SRM Dental College |
| Address |
Dept. of Conservative Dentistry
Second floor
Main block
SRM Dental College
Bharathi Salai
Ramapuram
Chennai-600089
Chennai
TAMIL NADU
600089
India |
| Phone |
|
| Fax |
|
| Email |
kavithasanjeev02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.M.Parasakthi |
| Designation |
Ph.D Student |
| Affiliation |
SRM Dental College Ramapuram |
| Address |
Fifth floor
Dept. of Oral Pathology
Main block
SRM Dental College
Bharathi Salai
Ramapuram
Chennai-600089
Chennai
TAMIL NADU
600089
India |
| Phone |
|
| Fax |
|
| Email |
dr.parasakthi2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Dental College
Bharathi Salai
Ramapuram
Chennai- 600089.
Self-funded study |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [0] |
|
|
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 M Parasakthi |
SRM Dental College |
Dept. of Oral Pathology
Fifth floor
Bharathi Salai
Ramapuram
Chennai-600089
Chennai
TAMIL NADU |
9080998691
dr.parasakthi2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM DC IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
71.00 Year(s) |
| Gender |
Both |
| Details |
Intra-oral lesion or restricted mouth opening
Or suspected oral malignancy |
|
| ExclusionCriteria |
| Details |
Those who are unwilling to participate in study
Those with other types of cancers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identifying biomarkers to understand disease progression |
3 years down the line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Biomarker based early detection in oral cavity |
3 years down the line |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2025 |
| Date of Study Completion (India) |
20/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A double-blind clinical trial has been completed to detect oral premalignancies and cancer at an early stage. The chosen biomarkers for this study were microRNA 372 and 486-3p. Patients who come for routine dental checkups were screened for intra-oral lesions, and saliva samples were collected from them. This study was designed with a sample size of 80, with 20 patients each in Oral cancer, Oral submucous fibrosis, Leukoplakia and controls.
|