| CTRI Number |
CTRI/2024/10/075121 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
RETROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
Perioperative drug use in oral cancer recurrence |
|
Scientific Title of Study
|
Perioperative drug exposure in oral cancer patients and its influence on oncological outcome: A Retrospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashwin Bhagchandani |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of Pharmacology,
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9770160092 |
| Fax |
|
| Email |
17yashwin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shalini Adiga |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Pharmacology,
KMC Manipal
KARNATAKA
576104
India |
| Phone |
9448521328 |
| Fax |
|
| Email |
shalini.adiga@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Yashwin Bhagchandani |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College ,Manipal |
| Address |
Department of Pharmacology,
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9770160092 |
| Fax |
|
| Email |
17yashwin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College ,Manipal ,Karnataka ,576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Department of Pharmacology, KMC Manipal ,Manipal ,Karnataka ,576104 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Yashwin Bhagchandani |
Kasturba Medical College ,Manipal |
Department of Pharmacology KMC Manipal
Udupi
KARNATAKA |
9770160092
17yashwin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE and KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE 2 STUDENT RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with oral cancer and undergone surgery between January 2018 and June 2021
Patients diagnosed with oral cancer and confirmed histopathologicaly
All cases of Stage 2 and Stage 3
Patients have been there for follow up for at least 3 year at Kasturba Hospital Manipal
|
|
| ExclusionCriteria |
| Details |
All cases of Stage 4 oral cancer
Patients with incomplete medical records or insufficient follow-up data
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
the proportion of patients who experienced recurrence of oral cancer within a timeframe of at least 3 years
Evaluate the pattern of use and association of drugs (peri operative) used in oral cancer management on time to recurrence and overall survival
|
Every Year for 3 Years or Till Recurrence |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Influence of treatment modalities (surgery, radiation therapy, chemotherapy) on both overall survival & time to recurrence |
Every Year for 3 Years or Till Recurrence |
|
|
Target Sample Size
|
Total Sample Size="364"
Sample Size from India="364"
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)
|
14/10/2024 |
| 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)
|
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
|
This study is aimed to find association between peri operative drugs used in oral cancer and effect on cancer recurrence and their economic burden of rercurrence. Primary Objectives- To determine the proportion of patients who experienced recurrence of oral cancer within a timeframe of at least 3 years.
To evaluate the pattern of use and association of drugs (peri operative) used in oral cancer management on time to recurrence and overall survival.
To evaluate the pattern of use and association of concomitant medication and used in oral cancer patients on overall survival and time to recurrence. Secondry Objective- To investigate the influence of treatment modalities (surgery, radiation therapy, chemotherapy) on both overall survival and time to recurrence. Cost of illness analysis in management of oral cancer. |