| CTRI Number |
CTRI/2024/05/066853 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Expression of a biomarker like Polyoma Enhancer Activator 3 may be higher in tooth-related neoplasms when compared to cysts. |
|
Scientific Title of Study
|
Immunohistochemical Expression of Polyoma Enhancer Activator 3 in Odontogenic Cysts and Tumors: An Observational Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Disha Naresh |
| Designation |
Post Graduate Student |
| Affiliation |
Institute of Dental Sciences |
| Address |
Department of Oral Pathology and Microbiology Institute of Dental Sciences Pilibhit Bypass road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9411631638 |
| Fax |
|
| Email |
naresh.disha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudan Astekar |
| Designation |
Professor & Head |
| Affiliation |
Institute of Dental Sciences |
| Address |
Department of Oral Pathology and Microbiology
Institute of Dental Sciences Pilibhit Bypass road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7599247899 |
| Fax |
|
| Email |
madhu.tanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhusudan Astekar |
| Designation |
Professor & Head |
| Affiliation |
Institute of Dental Sciences |
| Address |
Department of Oral Pathology and Microbiology
Institute of Dental Sciences Pilibhit Bypass road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7599247899 |
| Fax |
|
| Email |
madhu.tanu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Sciences
Pilibhit bypass road
Bareilly Uttar Pradesh India
pin code 243006 |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Sciences |
| Address |
Pilibhit Bypass Road
Bareilly, Uttar Pradesh
India
pin code 243006 |
| Type of Sponsor |
Other [Private 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 |
| Institute of Dental Sciences |
Institute of dental Sciences |
Room no.327 Department of oral and maxillofacial pathology and microbiology
Pilibhit bypass road
Bareilly Uttar Pradesh India
pin code 243006
Bareilly
UTTAR PRADESH |
05812526244
info@idsbareilly.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Dental Sciences Bareilly U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D103||Benign neoplasm of other and unspecified parts of mouth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Tissue blocks of odontogenic cysts that have been verified histopathologically
2 Tissue blocks of odontogenic tumors that have been verified histopathologically
|
|
| ExclusionCriteria |
| Details |
Insufficient clinical data
Tissues where controls exhibit unexpected results
Tissues fixed in fixatives other than neutral buffered formalin
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Immunohistochemical expression of polyoma enhancer activator 3 will be higher in odontogenic tumors as compared to cysts. |
NA |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
21/05/2024 |
| 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="0"
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
|
Protein kinase (MAPK) pathway activation is a significant event in the pathogenesis of odontogenic lesions.2,6 It has been observed that PEA3 is a major downstream effector of MAPK signaling, which is often abnormally activated in tumors. A literature review shows that very few studies have been conducted on the PEA3 marker in odontogenic lesions, which can further provide valuable information for diagnostic, prognostic, and therapeutic strategies. Therefore,the present study will be carried out to assess the expression of PEA3 in odontogenic cysts like the odontogenic keratocyst/dentigerous cyst and tumors such as ameloblastoma.
|