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CTRI Number  CTRI/2019/12/022485 [Registered on: 23/12/2019] Trial Registered Prospectively
Last Modified On: 10/07/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Single Arm Prospective study 
Study Design  Single Arm Study 
Public Title of Study   Depth of Invasion in oral cancer - Is clinical examination valid? 
Scientific Title of Study   Validation of Clinical measurement of depth of invasion for staging in Oral Cancer patients according to 8th AJCC 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mahesh Sultania 
Designation  Assistant Professor 
Affiliation  All india Institute of Medical Sciences, Bhubaneswar 
Address  Department Of Surgical Oncology, All India Institute Of Medical Sciences, Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9999330769  
Fax    
Email  drmaheshsultania@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mahesh Sultania 
Designation  Assistant Professor 
Affiliation  All india Institute of Medical Sciences, Bhubaneswar 
Address  Department Of Surgical Oncology, All India Institute Of Medical Sciences, Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9999330769  
Fax    
Email  drmaheshsultania@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mahesh Sultania 
Designation  Assistant Professor 
Affiliation  All india Institute of Medical Sciences, Bhubaneswar 
Address  Department Of Surgical Oncology, All India Institute Of Medical Sciences, Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9999330769  
Fax    
Email  drmaheshsultania@gmail.com  
 
Source of Monetary or Material Support  
Imaging studies, blood investigationsand histopathological studies are being done by AIIMS, Bhubaneswar free of cost or with minimal charge. It has been approved by ethical committee of the institute. Address is - Department of Surgical Oncology, AIIMS, Patrapada, Bhubaneswar, Odisha - 751019  
 
Primary Sponsor  
Name  All india Institute of Medical Sciences Bhubaneswar 
Address  All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar 
Type of Sponsor  Research institution and hospital 
 
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 
Mahesh Sultania   All india Institute of Medical Sciences  Room No1, Fifth Floor, Department Of Surgical Oncology, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA 		 9999330769

drmaheshsultania@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Measurement of Depth of Invasion  Newly diagnosed patients of Squamous Cell Carcinoma oral cavity – oral tongue and buccal mucosa with T1-3 lesions and presenting to Surgical Oncology OPD- Head and Neck clinic at AIIMS, Bhubaneswar will be recruited for the study after proper informed consent. Clinical assessment of depth of invasion will be done by a resident and two faculty of the department.Readings will be recorded individually in the proforma sheet, one each with the faculty and resident. MRI evaluation with be done if not done previously and the depth of invasion will be assessed based on MRI findings by one faculty and one resident from the Radiodiagnosis department. Findings will be recorded individually on the proforma provided. The mean value will be calculated based on clinical assessment and radiological assessment separately for each patient. All investigators will be blinded to each other’s findings and assessment. All patients will be prepared pre-operatively as per institutional protocol and will undergo surgical resection with or without neck dissection. Post-surgery the depth of invasion will be assessed on the histopathological specimen grossly and microscopically on freshly harvested specimen and the formalin fixed specimen. This reading as per final histopathological report will be recorded in the proforma. Depth of invasion will be measured from the level of normal mucosato the deepest point of the tumour for clinical assessment and similarly in paraffin embedded sections.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Histopathologicalevidence of squamous cell carcinoma in oral cavity.
2. Patients giving consent for the planned oral surgery.
3. Clinically T1- T3 lesions as per AJCC 8th edition
 
 
ExclusionCriteria 
Details  1. Tumors of other than squamous histology.
2. Patients who have receivedChemotherapy/ Radiation therapy
3. Patients having undergone excision biopsy
4. Not undergone MRI as imaging modality
5. Patients with second primary tumors.
6. Patients refusing to give consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To establish the correlation between clinical and histopathological assessment of depth of invasion in case of oral cancer.  1. Clinical Assesment Before Surgery
2. After Imaging
3. After Resection/Surgery
4. After Fixation of Specimen 
 
Secondary Outcome  
Outcome  TimePoints 
To study the correlation between pattern of invasion with grade of disease, nodal status and final stage of the disease.   1. Clinical Assesment Before Surgery
2. After Imaging
3. After Fixation of Specimen 
To estimate the extent of tumor shrinkage in formalin fixed specimen.

 		 1. After Resection/Surgery
2. After Fixation of Specimen
 
To estimate the surgical margin shrinkage in formalin fixed specimen.  1. Intraoperatively
2. After Resection/Surgery
3. After Fixation of Specimen 
 
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)   23/12/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Depth of Invasion evaluation in early oral cancer can be done clinically by palpation of the tumor and radiologically by using MRI. Clinical assessment is subjective and affected by trismus, location, subnucus fibrosis and inter observer bias. MRI is the investigation of choice. Gold standard is histopathological depth of invasion. This study is an effort to suggest that clinical assessment of depth of invasion correlated well with radiological and final histopathology. We will also look for surgical margin assessment and patter of invasion and correlate with grade of tumor, nodal status and final stage of the disease.  
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