| CTRI Number |
CTRI/2021/02/031118 [Registered on: 09/02/2021] Trial Registered Prospectively |
| Last Modified On: |
08/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Analytical |
| Study Design |
Other |
|
Public Title of Study
|
CLINICAL, RADIOLOGICAL AND HISTOLOGICAL COMPARISON OF DEPTH OF INVASION IN ORAL CAVITY CANCER |
|
Scientific Title of Study
|
A CLINICOPATHOLOGICAL AND RADIOLOGICAL EVALUATION OF DEPTH OF INVASION IN CARCINOMA ORAL CAVITY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divyanshi Singh |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Department of Otorhinolaryngology, IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418725107 |
| Fax |
|
| Email |
divyanshi7singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R S Minhas |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Department of Otorhinolaryngology, IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018162141 |
| Fax |
|
| Email |
drraviminhas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R S Minhas |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Department of Otorhinolaryngology, IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018162141 |
| Fax |
|
| Email |
drraviminhas@yahoo.com |
|
|
Source of Monetary or Material Support
|
| INDIRA GANDHI MEDICAL COLLEGE AND HOSPITAL, SHIMLA |
|
|
Primary Sponsor
|
| Name |
Dr Divyanshi Singh |
| Address |
Department of Otorhinolaryngology, IGMC, Shimla |
| Type of Sponsor |
Other [SELF] |
|
|
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 Divyanshi Singh |
IGMC, SHIMLA |
Department of Otorhinolaryngology, IGMC, Shimla
Shimla
HIMACHAL PRADESH |
8219424706
divyanshi7singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE IGMC, SHIMLA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with
1.Carcinoma buccal mucosa
2.Carcinoma anterior two-third part of tongue
3.Carcinoma floor of mouth
and who are eligible for wide local excision of the tumour.
|
|
| ExclusionCriteria |
| Details |
Patients with
1.Carcinoma base of tongue
2.Carcinoma retromolar trigone area
3.Carcinoma posterior one-third part of tongue
4.Restricted mouth opening where ultrasound probe cannot be manipulated
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the feasibility of ultrasonography in assessing the depth of invasion in carcinoma oral cavity |
The ultrasonographic assessment of depth of invasion will be done pre operatively which will be compared to depth of invasion on histopathological examination of the surgical specimen post-operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find accuracy of ultrasonography in assessment of depth of invasion in the oral cavity carcinoma.
2.To find accuracy of clinical examination and Contrast Enhanced Computed Tomography in assessing depth of invasion in the oral cavity carcinoma.
3.To compare clinical examination, ultrasonography and Contrast Enhanced Computed Tomography findings in assessment of depth of invasion in oral cavity carcinoma.
|
The clinical, ultrasonographic and contrast enhanced computed tomography assessment of depth of invasion will be done pre operatively which will be compared to depth of invasion on histopathological examination of the surgical specimen post-operatively. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
09/02/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THE PATIENT WILL BE EXAMINED CLINICALLY AND DEPTH OF INVASION OF THE ORAL CAVITY CANCER WILL BE ASSESSED WHICH WILL BE FURTHER ASSESSED BY ULTRASONOGRAPHY, CONTRAST ENHANCED COMPUTED TOMOGRAPHY AND HISTOPATHOLOGICAL EXAMINATION OF THE SURGICAL RESECTED SPECIMEN. THE DEPTH OF INVASION ON HISTOPATHOLOGICAL EXAMINATION IS CONSIDERED THE GOLD STANDARD. THE STUDY IS A PROSPECTIVE ANALYTICAL STUDY TO FIND THE FEASIBILITY OF ULTRASONOGRAPHY IN ASSESSMENT OF THE DEPTH OF INVASION IN CARCINOMA ORAL CAVITY. |