| CTRI Number |
CTRI/2025/06/089863 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Checking for Common Viruses in White Patches in the Mouth (Oral Leukoplakia) |
|
Scientific Title of Study
|
Co-existence of viral infections in Oral Leukoplakia: A Clinical and Molecular Study |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKASH DATTATRAY BADE |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8408909759 |
| Fax |
|
| Email |
akashbade131299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Surendraprasad Mishra |
| Designation |
Professor and Head |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9890515247 |
| Fax |
|
| Email |
sunil.mishra@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
AKASH DATTATRAY BADE |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8408909759 |
| Fax |
|
| Email |
akashbade131299@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Research Facility, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Pune-411018, Maharashtra State, India |
|
|
Primary Sponsor
|
| Name |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Sant Tukaram Nagar, Pimpri, Pune- 411018 |
| Type of Sponsor |
Other [Dental College] |
|
|
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 Sunil Surendraprasad Mishra |
Dr. D. Y. Patil Dental College and Hospital |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA |
9890515247
sunil.mishra@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years or older with clinically diagnosed Oral Leukoplakia (OL).
Willingness to provide informed consent and tissue samples for molecular and histopathological analysis.
|
|
| ExclusionCriteria |
| Details |
Presence of other/co-existing oral potentially malignant disorders or malignancies.
Immunocompromised individuals.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expression of viral oncoproteins (e.g., HPV-E6, EBV-LMP1) via IHC |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of HPV, EBV, & HSV infections in OL |
baseline |
| Correlation of viral presence with histopathological grade of dysplasia |
baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/07/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study will check for viral infections in people who have oral white patches (oral leukoplakia), which can turn into cancer. We will collect samples like saliva and blood, and analyze them using laboratory tests to detect viruses. The goal is to find whether viruses like HPV or EBV are linked to disease severity. |