| CTRI Number |
CTRI/2025/08/092419 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Tracking the Genetic Roots of Oral Cancer in India |
|
Scientific Title of Study
|
Identification of genomic biomarkers for oral cancers in Indian patients |
| 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 Akshat Malik |
| Designation |
Principal Consultant |
| Affiliation |
Max Super speciality Hospital East Block, A unit of Devki Devi Foundation |
| Address |
First Floor, East Block
Max Super speciality Hospital East Block, A unit of Devki Devi Foundation
2, Press enclave Road,Saket
South
DELHI
110017
India |
| Phone |
8219678863 |
| Fax |
|
| Email |
akshat.malik@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshat Malik |
| Designation |
Principal Consultant |
| Affiliation |
Max Super speciality Hospital East Block, A unit of Devki Devi Foundation |
| Address |
First Floor, East Block
Max Super speciality Hospital East Block, A unit of Devki Devi Foundation
2, Press enclave Road,Saket
South
DELHI
110017
India |
| Phone |
8219678863 |
| Fax |
|
| Email |
akshat.malik@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshat Malik |
| Designation |
Principal Consultant |
| Affiliation |
Max Super speciality Hospital East Block, A unit of Devki Devi Foundation |
| Address |
First Floor, East Block
Max Super speciality Hospital East Block, A unit of Devki Devi Foundation
2, Press enclave Road,Saket
South
DELHI
110017
India |
| Phone |
8219678863 |
| Fax |
|
| Email |
akshat.malik@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IIT Delhi |
| Address |
Indian Institute of Technology Delhi
Hauz Khas, New Delhi, Delhi 110016 |
| Type of Sponsor |
Research institution |
|
|
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 Akshat Malik |
Max Super speciality Hospital East Block, A unit of Devki Devi Foundation |
First Floor, East Block
Max Super speciality Hospital East Block, A unit of Devki Devi Foundation 2, Press enclave Road,Saket
South
DELHI
110017
India
South
DELHI |
9810772629
Akshat.Malik@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Oral cancer
Undergoing curative resection
Stages I-IV |
|
| ExclusionCriteria |
| Details |
Prior chemo/radiotherapy
Previous cancer
Not giving consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study will provide genomic information about Indian patients with oral cancers. This will
help us in developing targeted diagnostic platforms and help in tailoring theranostic
modalities. |
We propose to start this study by August 2025 and hope to finish within 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2025 |
| 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 Yet Recruiting |
| 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
|
In recent years, genomic data is being captured for various cancers, this has allowed better
understanding of the genomic variations in the patients. This has potential to help in
personalizing treatment.There is limited data available regarding genomic variation of oral cancers. Major data
which is available is from Western countries. There have only been a few studies which have
evaluated this in Indian cohorts.
The genomic data can help us understand which lesions can progress to malignancy, where
there will be higher chances of recurrences, detecting such recurrences early, predicting
treatment outcomes and thus being able to personalize therapies |