| CTRI Number |
CTRI/2026/01/102329 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The blood vessel changes for prediction of aggressiveness of oral squamous cell carcinoma as compared to routine guidelines.
|
|
Scientific Title of Study
|
Assessing the utility of CD 34 expression as an immunohistochemical marker for tumor behaviour in comparison to histopathological parameters and Tumour, Lymph nodes, Metastasis staging in oral squamous cell carcinoma. |
| 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 Yukti Mehta |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Pathology, 1st floor, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7988868641 |
| Fax |
|
| Email |
imymehta.ym@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samarth Shukla |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Pathology, 1st floor, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
8830267710 |
| Fax |
|
| Email |
samarth21174@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samarth Shukla |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Pathology, 1st floor, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha.
MAHARASHTRA
442001
India |
| Phone |
8830267710 |
| Fax |
|
| Email |
samarth21174@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha |
| Type of Sponsor |
Private medical 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 Yukti Mehta |
Datta Meghe Institute of Higher Education, Sawangi, Wardha |
Department of oral maxillofacial surgery and Department of Pathology, Histopathology Section
Wardha
MAHARASHTRA |
7988868641
imymehta.ym@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (2) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (3) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (4) ICD-10 Condition: C062||Malignant neoplasm of retromolar area, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Already diagnosed cases of oral squamous cell carcinoma on Histopathology.
All cases with Composite resection of lesion plus suitable Modified radical neck dissection (MRND) plus reconstruction with microvascular flap
Primary cases of Oral squamous cell carcinoma without any history of previous treatment.
All patients with oral squamous cell carcinoma arising Denovo
|
|
| ExclusionCriteria |
| Details |
All cases of benign lesions of oral cavity
All cases of malignancy other than oral squamous cell carcinoma.
All patients with oral squamous cell carcinoma where cancer is arising as a result of recurrence.
Cases with previous history of chemotherapy and radiotherapy.
All defaulted patients
Patients with no histological confirmation of oral squamous cell carcinoma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the expression of CD 34 in oral squamous carcinoma and compare it with College of American Pathologists( CAP)guidelines. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/02/2026 |
| 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="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
|
Oral cancer remains one of the ten most prevalent cancers globally and poses a significant public health challenge, particularly in low and middle-income countries. Despite being largely preventable, its frequent diagnosis at advanced stages contributes to poor clinical outcomes and high mortality rates. Among the various forms of oral malignancies, oral squamous cell carcinoma (OSCC) is the most predominant, typically arising in the oral cavity and often evolving from potentially malignant disorders. The global incidence of oral cancer is substantial, with approximately 405000 new cases reported annually. The burden is particularly high in South Asia and certain regions of Europe, where lifestyle and environmental risk factors are prevalent. Clinically, OSCC may initially present as asymptomatic red (erythroplakia) or white (leukoplakia) patches. Without early intervention, these lesions may progress to ulcerated, indurated nodules with raised margins, indicating advanced disease. The College of American Pathologists protocol for oral squamous cell carcinoma (OSCC) outlines key histopathological parameters vital for diagnosis. Tumor size, site, and depth of invasion (DOI) are essential for AJCC 8th edition staging, with DOI strongly linked to nodal metastasis. Histologic type and grade help assess tumor aggressiveness. Perineural (PNI) and lymphovascular invasion (LVI) indicate higher recurrence risk and may warrant adjuvant therapy. Margin status is critical positive or close margins increase local recurrence. These parameters, along with nodal status and dysplasia at margins, guide early diagnosis , staging and treatment planning. Immunohistochemical approaches using markers such as pan-cytokeratin, CD34, alpha SMA, E cadherin, and vimentin have enhanced the detection and interpretation of these features, offering deeper insights into tumor behavior. Another critical factor in the progression and aggressiveness of OSCC is angiogenesis the formation of new blood vessels that support tumor growth and metastasis. Angiogenesis is commonly evaluated by measuring microvessel density (MVD), a parameter that has shown strong correlation with tumor invasiveness and poor prognosis. Immunohistochemistry is a technique for identifying cellular or tissue constituents (antigens) by means of antigen-antibody interactions. One such marker ,particularly CD34 a transmembrane glycoprotein expressed on endothelial cells are widely used to quantify MVD in lung colon, breast , stomach, prostate and bladder cancers and malignant melanomas. The disappearance of CD34 positive stromal cells are linked with the conversion of squamous intraepithelial lesions (SILs) to SCC. Complete disappearance of CD34 positive cells in the stroma in SCC indicates that they could have been converted into myofibroblasts. The appearance of CD34 positive endothelial cells plays a vital role in understanding the process of angiogenesis in oral cancer and pre-cancer.CD34 not only helps identify tumor-associated neovascularization but also serves as a valuable marker that can aid in treatment planning. To Assess the utility of CD34 expression as an immunohistochemical marker for tumor behaviour in comparison to histopathological parameters and tumour, lymph nodes, metastasis staging in oral squamous cell carcinoma. |