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CTRI Number  CTRI/2023/11/059759 [Registered on: 13/11/2023] Trial Registered Prospectively
Last Modified On: 27/10/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of oral cancer  
Scientific Title of Study   Evaluation of tumour budding as a prognostic marker 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 Amit Kumar Chowhan 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences (AIIMS), Raipur 
Address  Department of Pathology and Lab Medicine, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9490398668  
Fax    
Email  chowhanpath@aiimsraipur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Kumar Chowhan 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences (AIIMS), Raipur 
Address  Department of Pathology and Lab Medicine, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9490398668  
Fax    
Email  chowhanpath@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Amit Kumar Chowhan 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences (AIIMS), Raipur 
Address  Department of Pathology and Lab Medicine, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9490398668  
Fax    
Email  chowhanpath@aiimsraipur.edu.in  
 
Source of Monetary or Material Support  
Institute Research Cell, AIIMS Raipur 
 
Primary Sponsor  
Name  Dr Amit Kumar Chowhan 
Address  Department of Pathology and Lab Medicine, AIIMS Raipur 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Kumar Chowhan  AIIMS HOSPITAL AND MEDICAL COLLEGE, RAIPUR  Room No. 3221, Department of Pathology and Lab Medicine, Third floor, Medical college building.
Raipur
CHHATTISGARH 		 9490398668

chowhanpath@aiimsraipur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (3) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (4) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (5) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (6) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (7) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Surgically resected specimens of oral cavity and diagnosed as Squamous Cell Carcinoma on histopathological examination will be included in the study. 
 
ExclusionCriteria 
Details  History of chemotherapy or radiation therapy prior to surgery will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Tumour budding  Three months  
 
Secondary Outcome  
Outcome  TimePoints 
understand association of tumour budding with epithelial mesenchymal transition phenomenon  Three months  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   24/11/2023 
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 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   Oral Squamous Cell Carcinoma (OSCC) is the most common epithelial malignancy of the oral cavity. Since the age old era, many histopathological parameters like tumour size, depth of invasion, etc. are studied as prognostic indicators. But the overall 5-year survival rate of OSCC has still not improved. Seeing the burden of disease, there is a need to study other prognostic markers. An emerging histopathological marker for tumour invasion and metastasis is tumour budding (TB), defined as an isolated tumours cells or small clusters (<5 cells) of tumour cells present in the stroma along the invasive margin of the tumour. Its role has already been established as an independent prognostic factor in colorectal, lung, and breast carcinoma. However, very few studies highlight its role in OSCC. TB is considered as a histopathological marker of loss of cellular adhesion, and thus, it is closely associated with epithelial-mesenchymal transition (EMT), which is the hallmark of invasion and metastasis. This study will help to understand the tumour budding in OSCC, its correlation with grade and stage of tumour and with EMT phenomenon, which promotes invasion and distant metastasis, leading to decrease in overall survival rate.  
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