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
|
|
Primary Sponsor
|
Name |
NA |
Address |
NA |
Type of Sponsor |
Other [NA] |
|
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 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
|
|
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
|
|
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. |