| CTRI Number |
CTRI/2017/10/010125 [Registered on: 18/10/2017] Trial Registered Prospectively |
| Last Modified On: |
06/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Screening and detection of oral cancer |
|
Scientific Title of Study
|
Multi-centric Study for Screening and detection of oral potentially malignant disorders (OPMD) non-invasively by fluorescence and diffuse reflectance imaging with OralScan camera, and development of an algorithm for tissue discrimination |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhash Narayanan |
| Designation |
Chief Scientist |
| Affiliation |
SASCAN MEDITECH PVT LTD |
| Address |
NS402 Shriram Surabhi
Talaghattapura
Holiday Village Rd
Bangalore
Centre for Innovation in Medical Electronics
BMS College of Engineering
Bull Temple Road
Basavanagudi
Bangalore 560019
Bangalore
Bangalore
KARNATAKA
560109
India |
| Phone |
9591345016 |
| Fax |
|
| Email |
subhashnarayanan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhash Narayanan |
| Designation |
Chief Scientist |
| Affiliation |
SASCAN MEDITECH PVT LTD |
| Address |
NS402 Shriram Surabhi
Talaghattapura
Holiday Village Rd
Bangalore
Centre for Innovation in Medical Electronics
BMS College of Engineering
Bull Temple Road
Basavanagudi
Bangalore 560019
Bangalore
Bangalore
KARNATAKA
560109
India |
| Phone |
9591345016 |
| Fax |
|
| Email |
subhashnarayanan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhash Narayanan |
| Designation |
Chief Scientist |
| Affiliation |
SASCAN MEDITECH PVT LTD |
| Address |
NS402 Shriram Surabhi
Talaghattapura
Holiday Village Rd
Bangalore
Centre for Innovation in Medical Electronics
BMS College of Engineering
Bull Temple Road
Basavanagudi
Bangalore 560019
Bangalore
Bangalore
KARNATAKA
560109
India |
| Phone |
9591345016 |
| Fax |
|
| Email |
subhashnarayanan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Startup Cell,
KBITS,
Department of IT and BT,
BMTC Building,
B Block,
KH Road,
Bangalore 560027 |
| Sascan Meditech Pvt Ltd,
NS 402, Shriram Surabhi,
Holiday Village Road,
Talaghattapura,
Bangalore 560 109 |
|
|
Primary Sponsor
|
| Name |
Sascan Meditech Pvt Ltd |
| Address |
Centre for Innovation in Medical Electronics
BMS College of Engineering
Bull Temple Road
Bangalore 560 019
|
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KIBITS |
Dept of IT&BT
BMTC Building B Block
KH Road Bangalore 560 027 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Liz John Carol |
Bangalore Baptist Hospital |
Oral Medicine Laboratory, Research Department,
Community Block,
Bellary Road,
Hebbal,
Bangalore 560024
Bangalore
KARNATAKA |
9972156838
carolinelizabethj@gmail.com |
| Dr U S Vishal Rao |
HCG Bangalore Institute of Oncology |
Head and Neck Oncology Department, No. 8 HCG Towers
P Kalinga Rao Road,
Sampangi, Ram Nagar,
Bangalore 560027
Bangalore
KARNATAKA |
9739774949
drvishalrao@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| GDC Kottayam Ethics Committee |
Approved |
| HCG Central Ethics Committee |
Approved |
| JSS Dental College & Hospital Ethics Committee Mysore |
Approved |
| Sree Balaji Dental College & Hospital Ethics Committee Chennai |
Approved |
| Sum Hospital Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Men and women above 20 years with OPMD lesions such as leukoplakia, erythroplakia, OSMF, dysplasia and moderate to well differentiated squamous cell carcinoma., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with oral potentially malignant disorder (OPMD) lesions such as leukoplakia, erythroplakia, oral sub mucous fibrosis (OSMF), dysplasia and moderate to well differentiate squamous cell cancer.
2.Healthy Volunteers without tobacco/pan/gutka/arrecanut/cigarette or beedi smoking/alcohol habits and any visible symptoms of other diseases or tissue inflammation in the oral cavity |
|
| ExclusionCriteria |
| Details |
1.Previous treatments for cancer.
2.Patients with systemic conditions that contraindicates biopsy.
3.Recent application of any medication orally for at least four weeks.
4.Patients not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Testing the accuracy of the device to locate the most malignant site in a lesion for biopsy. |
Two weeks of patient enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Development of an algorithm to discriminate different types and grade cancer.
2. Determining the diagnostic accuracy of the device for discrimination of OPMD |
One year from the start of trial |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "336"
Final Enrollment numbers achieved (India)="336" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2017 |
| Date of Study Completion (India) |
30/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/12/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
A manuscript is under consideration of the Journal of Biomedical Optics under the title "Bimodal multispectral imaging system with cloud-based machine learning algorithm for 1 real-time screening and detection of oral potentially malignant lesions and biopsy guidance" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The current screening modality practiced in India for detection of oral cancer is visual examination with white light. However, with white light examination, clinicians find it very challenging to locate the most malignant site for biopsy, leading to multiple biopsies or under-diagnosis and unnecessary biopsies. Sascan Meditech Pvt Ltd has developed a non-invasive device (OralScan) based on tissue fluorescence and diffuse reflectance imaging to screen and detect oral precancers in real time. The device consists of multiple LEDs to illuminate the tissue and a monochrome camera to capture multiple images on sequential switching of these LEDs. The device is connected to a tablet or PC for control using proprietary software. which also takes care of image processing and analysis. The primary purpose of the study is to test the capability of the device to visualize oral potentially malignant diseases (OPMD) of the oral cavity and identify the most malignant site in the lesion for tissue biopsy, so that under-diagnosis is avoided. This would be carried out by comparing the accuracy of the current practice with that of the device in this trial. No biopsy will be taken from healthy subjects. The fluorescence images and diffuse reflectance image ratios will be correlated with pathological data and an algorithm would be developed for determining the grade of cancer in real time. The diagnostic accuracy of the device will also be assessed. It is hoped that device would evolve as a biopsy guidance tool for clinicians and avoid the large number of false negatives and false positives associated with current practice and help reduce oral cancer burden. |