| CTRI Number |
CTRI/2024/12/078020 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Use of Artificial Intelligence to find out early Oral Cancer and Oral Cancer cases using smartphone based photographic images.
|
|
Scientific Title of Study
|
Use of Artificial Intelligence’s deep learning algorithm based Convolutional Neural
Network for automatic types and detection of Oral Potentially Malignant Disorders and
Oral Squamous Cell Carcinoma in smartphone based photographic images for early
diagnosis A cross sectional 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 |
Dr Manjari Chaudhary |
| Designation |
Lecturer |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room No 1
Department of Oral Medicine and Radiology
Sharad Pawar Dental College and Hospital
Sawangi, Wardha, Maharashtra
Wardha
MAHARASHTRA
442107
India |
| Phone |
7044455554 |
| Fax |
|
| Email |
manjarichaudhary6329@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suwarna Dangore |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room no 1, Ground floor,
Department of Oral Medicine and Radiology.
Sharad Pawar Dental College and Hospital.
Sawangi, Wardha, Maharashtra
Wardha
MAHARASHTRA
442107
India |
| Phone |
9923024036 |
| Fax |
|
| Email |
dangore_suwarna@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjari Chaudhary |
| Designation |
Lecturer |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room No 1, Ground Floor
Department of Oral Medicine and Radiology
Sharad Pawar Dental College and Hospital.
Sawangi, Wardha, Maharashtra
Wardha
MAHARASHTRA
442107
India |
| Phone |
7044455554 |
| Fax |
|
| Email |
manjarichaudhary6329@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 1
Oral Medicine and Radiology
Sharad Pawar Dental College and Hospital
Datta Meghe Institute of Higher Education and Research
Datta Meghe Institute of Medical Sciences Campus
Sawangi Wardha 442107
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Dr Manjari Chaudhary |
| Address |
Room No 1
Oral Medicine and Radiology
Sharad Pawar Dental College and Hospital
Datta Meghe Institute of Higher Education and Research
Datta Meghe Institute of Medical Sciences Campus
Sawangi Wardha
Maharashtra
India |
| Type of Sponsor |
Other [self] |
|
|
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 Manjari Chaudhary |
Sharad Pawar dental College and hospital |
Sharad Pawar Dental College and Hospital
Datta Meghe Institute of Higher Education and Research , Sawangi, Wardha 442017
Wardha
MAHARASHTRA |
7044455554
manjarichaudhary6329@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DMIHER, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Use of Artificial Intelligence’s deep learning algorithm based Convolutional Neural
Network for automatic types and detection of Oral Potentially Malignant Disorders and
Oral Squamous Cell Carcinoma in smartphone based photographic images for early
diagnosis: A cross sectional study. |
Artificial Intelligence’s deep learning algorithm based Convolutional Neural Network for automatic types and detection of Oral Potentially Malignant Disorders and Oral Squamous Cell Carcinoma in smartphone based photographic images for early diagnosis. Total duration of intervention is 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are above 18 years of age, healthy people and subjects who are
diagnosed clinically with OPMD or OSCC.
2. The OPMD cases will be divided into homogeneous which will be low risk cases and
nonhomogeneous which will be high risk cases based on clinical manifestations. |
|
| ExclusionCriteria |
| Details |
Subjects who are undergoing treatment for OPMD or OSCC.
2. Subjects who are suffering from systemic diseases, severe internal accompanying
diseases like Systemic Lupus Erythematosus (SLE), Discoid Lupus Erythematosus
(DLE), HIV/AIDS, diagnosis of other tumours (for e.g.: laryngeal cancer or nasal cavity
tumours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Automatic types and detection of Oral Potentially Malignant Disorders and Squamous Cell Carcinoma |
Time points-assessed at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| automatic types and detection of Oral Potentially Malignant Disorders and Squamous Cell Carcinoma |
3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/01/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [manjarichaudhary6329@gmail.com].
- For how long will this data be available start date provided 04-11-2025 and end date provided 04-04-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A handheld smartphone (Iphone 14 pro) will be used to collect oral images Steps to be followed: 1. The camera grid of the handheld smartphone iPhone 14 Pro settings will be used to aid in locating the centre of the lesion. The faint grid keeps the area of lesion to be used as the fixed region of interest (ROI) as the grid is divided into nine rectangles of equal size. The camera grid helps the lesion to be placed at the centre for obtaining accurate and appropriate image. This will aid in removing any irrelevant backgrounds. 2. The images will be taken of only those patients who have given informed and approved consent. All methods will be carried out in accordance with relevant guidelines and regulations. 3. The appropriate image will be captured by keeping the smartphone camera in a way where the lesion is in the centre of the square of the grid without any blurring or errors. 4. The image will be uploaded with diagnostic software via Wi-Fi Data collection: The subjects will be screened independently, by the Oral Medicine specialist. The medical history and image collection will be carried out in the daily outpatient clinic of the Oral Medicine and Radiology department and on patients of the hospital. Histopathologic reports may be required if a subsequent biopsy is performed. Histopathologic reports will be considered as gold standard. A patient with Oral Cancer would have undergone histopathologic examination. As proposed by the American Joint Committee on Cancer (AJCC), according to the TNM clinical staging system, stage I-IV will be Oral Squamous Cell Carcinoma cancer. The OSCC images of lip, buccal mucosa, tongue, and hard palate, upper and lower alveolar ridge will be characterized as exophytic, or endophytic or ulcerative in various areas of the oral cavity. Homogenous or low risk OPMD, may not have a histopathologic report. Thus, based on clinical features, the oral images will be under 4 categories i.e., normal, homogenous OPMD, non-homogenous OPMD, and OSCC. A white patch or a lesion, uniformly flat and thin in nature, and have a smooth or fissured surface with no atrophic or erosive lesions will be considered as homogeneous OPMD. Non-homogenous OPMD will be mixed red and white lesions which are atrophied or with irregular surface texture. A nodular lesion from the mucosal surface or a deep ulcer with a rough surface, everted both with unclear borders will be considered as OSCC. 3. The normal healthy mucosa presents with homogenous, neither white nor red patches. Each lesion will have one picture. If there are multiple lesions in a patient then those many images will be taken. In a healthy individual, numerous oral images can be taken which belong to different anatomic sites of oral cavity like buccal mucosa, labial mucosa, tongue, palate and floor of the mouth. One oral medicine specialist will take part in this research project to ensure appropriate annotation and it will be quality reviewed by an expert. These images/ datasets obtained will be used to train CNN. Finally, CNN will be able to predict the oral squamous cell carcinoma and oral potentially malignant disorders via an input image. Following steps WILL BE performed: 1. Preprocessing: The central area is obtained by cropping the irrelevant structures from the image so as to obtain the useful part of the image. 2. All photographic images were uploaded to the web application for image annotation. 3. Due to manual segmentation, the image used for CNN training, validation, and testing will be the largest area of intersection annotations 4. CNN models will be used in order to classify and detect lesions in the oral photographic images 5. Some of the oral images will be randomly assigned as training data for OPMD, OSCC and normal oral mucosa. Some of the images will be used as validation and will be used as testing data to confirm the accuracy |