| CTRI Number |
CTRI/2024/12/077743 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Oral Cancers in a tertiary care centre |
|
Scientific Title of Study
|
Cross sectional observational study of Oral cancers in a tertiary care centre |
| 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 Anuja Kulkarni |
| Designation |
Consultant |
| Affiliation |
JRH Mumbai |
| Address |
Room No 5Jagjivan Ram Hospital Maratha Mandir Marg Mumbai Central Mumbai
Jagjivan Ram Hospital Maratha Mandir Marg Mumbai Central Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9819464115 |
| Fax |
|
| Email |
dr.anujakulkarni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ayushi Jain |
| Designation |
DNB Trainee |
| Affiliation |
JRH Mumbai |
| Address |
Room No 5
Jagjivan Ram Hospital, Maratha Mandir Marg Mumbai Central Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
pbsjrh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuja Kulkarni |
| Designation |
Sr DMO SG |
| Affiliation |
JRH Mumbai |
| Address |
Room No 5
Jagjivan Ram Hospital, Maratha Mandir Marg Mumbai Central Mumbai
MAHARASHTRA
400008
India |
| Phone |
9819464115 |
| Fax |
|
| Email |
dr.anujakulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jagjivan Ram Railway Hospital Maratha Mandir Marg, Mumbai Central Mumbai:400008 |
|
|
Primary Sponsor
|
| Name |
Jagjivan Ram Railway Hospital |
| Address |
Jagjivan Ram Railway Hospital Maratha Mandir Marg Mumbai Central Mumbai |
| Type of Sponsor |
Other [Govt Hospital] |
|
|
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 Anuja Kulkarni |
Jagjivan Ram Railway Hospital |
Room no 5Jagjivan Ram Hospital, Maratha Mandir Marg Mumbai Central Mumbai
Mumbai
MAHARASHTRA |
9819464115
dr.anujakulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC/JRH |
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 |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of oral cancer patients admitted in Jagjivan Ram Hospital, aged more than and equal 18 years and less than and equal 99 years irrespective of gender and comorbidities |
|
| ExclusionCriteria |
| Details |
Children less 18 years old
Pregnant women
Those who are not able to communicate and intubated patients
Unconscious patients mentally challenged patients
Patient will be withdrawn from the study if Patient is unwilling to continue or is unconscious
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration and quantity of consumption of tobacco, ethanol or any substance abuse
Duration of hospitalization
Length of time to clinical progression
•Assessment of speech and swallowing pre and post operatively by various scales
•Assessment of midarm circumference and chest girth pre and post treatment
•The patient will be followed up post-operative period for follow up assessment of speech and swallowing using the study instruments
|
at baseline 4 weeks 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disease Specific mortality |
1 month 3 month 6 month 1 year |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
14/12/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
|
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
|
Head and neck cancers, including oral cancers are the sixth most common cancer worldwide and are one of the commonest cancers in developing countries. India contributes to the second highest number of oral cancer cases in the world. Although, Consumption of tobacco, betel-quid chewing and excessive alcohol consumption may attribute to this cause., of late it is observed that there are cases of oral cancers which are non-tobacco, non-ethanol users. In spite of the best possible treatment the biology of oral cancer has posed challenge to clinicians across the globe. Hence the present study is proposed in order to study the epidemiology of oral cancer presented in a highly segregated cohort of patients presented in a tertiary care hospital
|