| CTRI Number |
CTRI/2025/03/082309 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mucoscopy and biopsy of oral white lesions |
|
Scientific Title of Study
|
A Cross-sectional observational study of correlation of Mucoscopic and Histopathological findings in Oral white lesions. |
| 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 Amruta Hiray |
| Designation |
Postgraduate resident |
| Affiliation |
Topiwala National Medical College and BYL Nair Ch. Hospital, Mumbai |
| Address |
Department of dermatology, OPD 14, 2nd floor, OPD building, Topiwala national medical college and BYL Nair Ch. hospital, Mumbai -400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8379054626 |
| Fax |
|
| Email |
amruta24hiray@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitra S Nayak |
| Designation |
Professor and HOD, Dept of dermatology |
| Affiliation |
Topiwala National Medical College and BYL Nair Ch. Hospital, Mumbai |
| Address |
Department of dermatology, OPD 14, 2nd floor, OPD building, Topiwala national medical college and BYL Nair Ch. hospital, Mumbai -400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9029495590 |
| Fax |
|
| Email |
chitranayak054@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chitra S Nayak |
| Designation |
Professor and HOD, Dept of dermatology |
| Affiliation |
Topiwala National Medical College and BYL Nair Ch. Hospital, Mumbai |
| Address |
Department of dermatology, OPD 14, 2nd floor, OPD building, Topiwala national medical college and BYL Nair Ch. hospital, Mumbai -400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9029495590 |
| Fax |
|
| Email |
chitranayak054@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of dermatology, OPD 14, 2nd floor, OPD building, Topiwala national medical college and BYL Nair Ch. hospital, Mumbai, Maharashtra, 400008, and India |
|
|
Primary Sponsor
|
| Name |
Dr Amruta Hiray |
| Address |
Department of dermatology, OPD 14, 2nd floor, OPD building, Topiwala national medical college and BYL Nair Ch. hospital, Mumbai -400008 |
| Type of Sponsor |
Other [self] |
|
|
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 Amruta Hiray |
Topiwala National Medical College and BYL Nair Ch. hospital, Mumbai -400008 |
Room no 12, OPD 14, second floor of OPD building
Mumbai
MAHARASHTRA |
8379054626
amruta24hiray@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects [ECARP] PG Academic Committee, TN. Medical College and BYL Nair Ch. Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.All the patients above 6 years of age presenting with oral white lesions who are not on any treatment for at least previous 3 months belonging to both sexes, willing to participate in the study through a written informed consent.
2.Patients willing for mucosal biopsy
|
|
| ExclusionCriteria |
| Details |
1.Patients with oral white lesions who have received treatment in the previous 3 months
2.Patients with platelet count below 1 lakh per microlitre, bleeding disorders, on oral aspirin, active herpes simplex or any other contraindications to oral biopsy.
3.Patients not willing to give written informed consent.
4.Age less than 6 years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mucoscopic features and Histopathological features of oral white lesions |
Baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
31/03/2025 |
| 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="8"
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
|
This is a cross-sectional observational study examining the correlation between mucoscopic and histopathological findings in oral white lesions. Patients meeting the inclusion criteria will be recruited. Mucoscopic and histopathological features will be studied and recorded. Each feature will be independently assessed by different individuals. The correlation between mucoscopic and histopathological features of oral white lesions will then be analyzed. |