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CTRI Number  CTRI/2017/01/007701 [Registered on: 13/01/2017] Trial Registered Retrospectively
Last Modified On: 03/11/2016
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To study CT scan accuracy in measuring tumor in case of buccal cancers 
Scientific Title of Study   To study the computed tomography (CT) scan accuracy in determining the tumor thickness and depth of invasion for gingivobuccal complex cancers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
1119  Protocol Number 
Version 1.0  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devendra Chaukar  
Designation  Professor & Surgical Oncologist  
Affiliation  Tata Memorial Hospital 
Address  Homi Bhabha Block Tata Memorial Hospital Dr. E. Borges Road Mumbai

Mumbai
MAHARASHTRA
400 012
India 
Phone  912224177000  
Fax    
Email  dchaukar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Devendra Chaukar  
Designation  Professor & Surgical Oncologist  
Affiliation  Tata Memorial Hospital 
Address  Homi Bhabha Block Tata Memorial Hospital Dr. E. Borges Road Mumbai


MAHARASHTRA
400 012
India 
Phone  912224177000  
Fax    
Email  dchaukar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Devendra Chaukar  
Designation  Professor & Surgical Oncologist  
Affiliation  Tata Memorial Hospital 
Address  Homi Bhabha Block Tata Memorial Hospital Dr. E. Borges Road Mumbai


MAHARASHTRA
400 012
India 
Phone  912224177000  
Fax    
Email  dchaukar@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Devendra Chaukar   Tata Memorial Hospital   Head & Neck OPD 2nd floor Homi Bhabha Block Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA 
02224177000
02224146392
dchaukar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics comittee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with histologically proven squamous cell carcinoma of the oral cavity with doubtful invasion of the skin as assessed clinically by the principal investigator will be enrolled in the study. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Histologically proven squamous cell carcinoma involving gingivobuccal complex
• Previously untreated gingivobuccal complex squamous cell carcinoma with doubtful invasion into the skin.
• Study specific signed informed consent
 
 
ExclusionCriteria 
Details  • Frank ulceration/ fungation of the skin by the tumor
• Non squamous pathology
• Prior surgery, chemotherapy or radiotherapy to head neck region
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the computed tomography (CT) scan accuracy in determining the depth of invasion for the tumor involving gingivobuccal complex  at time of CT scan procedure done 
 
Secondary Outcome  
Outcome  TimePoints 
To decide the thickness of the tumor and to calculate the distance of tumor from the skin   Before surgery 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 2 
Date of First Enrollment (India)   25/06/2013 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

50 patients with histologically proven squamous cell carcinoma of the oral cavity with doubtful invasion of the skin as assessed clinically by the principal investigator will be enrolled in the study.

The CT scan would be performed on 16 row MDCT (Multi Detector Computed Tomography) scanner with patient in supine position and after administration on intravenous iodine containing (300mg of iodine per ml) contrast. The scans would be performed from the root of the neck to the skull base with slice thickness of 2.5 mm, from the volume so acquired 0.625 thick slices would be generated for viewing in soft issue and bone algorithm and for multiplanar reformatting in coronal and sagittal planes.

From the images so generated, tumor dimensions including depth would be ascertained. Distance from the outermost edge of the tumor to the skin will be calculated by a senior radiologist. We also make a note of presence or absence and extent of fat stranding in the subcutaneous tissue, whether it (fat stranding) is reaching up to the skin and if there is skin thickening or infiltration by the lesion.

All these patients will be subjected to surgery and intraoperative decision to excise the skin will be taken by operating surgeon irrespective of the calculated distance between the tumor and the skin on CT scan. All resected specimens will be evaluated in accordance with a standardized protocol. This will entail recording the greatest antero-posterior (longitudinal) and medio-lateral (transverse) dimensions of the tumor in millimeters. The tumor will be sliced at 4-5 mm thickness, perpendicular to the tumor longitudinal axis. Maximum tumor thickness and the closest distance of the tumor from the skin (or the lateral soft tissue in cases where skin has not been removed) will be recorded. The tumor thickness, depth of invasion and distance from the overlying skin will be confirmed on microscopy. Presence of subdermal lymphatics and microscopic skin thickness will also be recorded.

                        

Comparison between CT & Histopathological Report (HPR) findings

 

 The  CT scan  findings  will  be  compared  with

 

histopathological findings using SPSS version 18, Chicago IL USA. Correlation method will be used to compare different variables. The depth of invasion or the maximum tumor thickness on CT scan will be compared with the depth of invasion / tumor thickness reported by the pathologist. Similarly comparison would be made of tumor dimensions in antero–posterior and transverse plane between CT scan and HPR findings. The comparison of values obtained by calculating the distance between the tumor and the skin on CT scan and that of those reported by pathologist would be made using correlation method. For each patient absence or presence of fat stranding would be compared with absence or presence of subdermal lymphatic invasion by the tumor cells reported on histopathology. 

 
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