| CTRI Number |
CTRI/2021/07/035059 [Registered on: 22/07/2021] Trial Registered Prospectively |
| Last Modified On: |
21/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Screening of Oral Cancer |
|
Scientific Title of Study
|
LIQUID BIOPSY FOR ORAL CANCER SCREENING USING SUPERHYDROPHOBIC SURFACE ENHANCED RAMAN PLASMONIC DROPLET ASSAY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sajan D George |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Atomic and Molecular Physics, LG -1, AB-5,
MIT campus, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7760595726 |
| Fax |
|
| Email |
sajan.george@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajan D George |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Atomic and Molecular Physics, LG -1, AB-5,
MIT campus, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7760595726 |
| Fax |
|
| Email |
sajan.george@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajan D George |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Atomic and Molecular Physics, LG -1, AB-5,
MIT campus, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7760595726 |
| Fax |
|
| Email |
sajan.george@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, Government of India |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| Address |
Department of Science and Technology, Technology Bhavan, New Mehrauli road, New delhi-110 016 |
| Type of Sponsor |
Government funding agency |
|
|
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 Keerthilatha M Pai |
Manipal College Of Dental Sciences |
Deans Office, Department of Oral Medicine and Radiology
Udupi
KARNATAKA |
9845637938
keerthilatha.pai@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital 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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All above 18 years of age and having malignant or benign type of oral cancer are included. |
|
| ExclusionCriteria |
| Details |
All patients below age 18 are excluded. Also, the subjects having co-morbidity conditions which does not allow biopsy will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study focuses on the development of a portable device based on optical SERS spectroscopic technique for the molecular fingerprinting of microliters of diluted saliva for the detecting oral cancer at an earlier stage. The usage of different multivariate statistical analysis tools will be helpful in analyzing the Raman spectroscopic data thereby differentiating them into different sets. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="159"
Sample Size from India="159"
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)
|
01/08/2021 |
| 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="2"
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 spectroscopy based techniques are emerging up as promising techniques for the early detection and screening of different types of cancers (e.g. Oral, breast, cervical etc.). Among them, Surface Enhanced Raman Spectroscopy(SERS) based analysis of body fluids can represent an alternative of tissue biopsy which is called as optical liquid biopsy. This single center observational study mainly aims the development of a portable device based on optical SERS spectroscopic technique for the molecular fingerprinting of microliters of diluted body fluids such as saliva and blood for detecting oral cancer at an earlier stage. Also, the superhydrophobic plasmonic array offers some advantages such as minimum requirement of sample as well as the concentration enhancement of analytes. In addition to this, the usage of different multivariate statistical analysis tools will help us differentiating the spectroscopic data into different datasets. The developed system for the early screening of oral cancer will be highly beneficial to the society to bring down the cervical cancer mortality rate. |