| CTRI Number |
CTRI/2024/04/065838 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A prospective study to collect images from oral cavity of adult participants having oral lesions to test an artificial intelligence-based algorithm’s performance for supporting the early detection of oral cancers. |
|
Scientific Title of Study
|
A prospective research study to collect images from oral cavity of participating subjects to test an artificial intelligence-based algorithm for supporting the early detection of oral cancers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Punnya S Rao |
| Designation |
Professor & Head Oral Pathology |
| Affiliation |
KLE Academy of Higher Education and Research |
| Address |
Department of Oral Pathology & Microbiology No 4
KLE Academy of Higher Education and Research JNMC Campus Nehru Nagar Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9880845530 |
| Fax |
|
| Email |
punnyasanjay@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dnyanesh Limaye |
| Designation |
Clinical Director |
| Affiliation |
Oraicle Biosciences Limited |
| Address |
A4 602 Phase 1 Aldea Espanola Puranik Society Mahalunge Near Orchid Hotel Radha Chowk Balewadi Pune
Pune MAHARASHTRA 411045 India |
| Phone |
91368873124 |
| Fax |
|
| Email |
dnyanesh@oraiclebio.com |
|
Details of Contact Person Public Query
|
| Name |
Mr Ayan Neogi |
| Designation |
Managing Director |
| Affiliation |
Vivforever Aesthetics Private Limited |
| Address |
103 A Bhairavi Doordarshan CHS Gokuldham Goregaon East Mumbai
Mumbai (Suburban) MAHARASHTRA 400063 India |
| Phone |
9967968612 |
| Fax |
|
| Email |
ayanneogi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Oraicle Biosciences Limited
Unit C Anchor House School Lane, Chandlers Ford, Eastleigh, England, SO53 4DY, United Kingdom |
|
|
Primary Sponsor
|
| Name |
Oraicle Biosciences Limited |
| Address |
Unit C Anchor House School Lane Chandlers Ford SO53 4DY United Kingdom |
| Type of Sponsor |
Other [Global Healthcare Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uma Datar |
Bharati Vidyapeeth Medical College & Hospital |
Medical College & Hospital, Sangli Miraj Road, Wanalesawadi Sangli Maharashtra 416416 Sangli MAHARASHTRA |
9595624566
dataruv@gmail.com |
| Dr Rajnish Nagarkar |
HCG Manavata Cancer Centre |
Department of Oral Cancer & Clinical Research Unit , 1st Floor, Unit 2, Near Mylan Circle, Mumbai Naka, Nashik, Maharashtra 422002 Nashik MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Punnya S Rao |
KLE VK Institute of Dental Sciences |
KLE VK Institute of Dental Sciences KLE Academy of Higher Education & Research JNMC Campus Nehru Nagar Belagavi 590010 Belgaum KARNATAKA |
9880845530
punnyasanjay@gmail.com |
| Dr Parag Watve |
Kolhapur Cancer Centre |
Head & Neck Cancer Department, A/p. R. S. No. 238, opp. Mayur Petrol Pump, Gokul Shirgaon, Maharashtra 416234 Kolhapur MAHARASHTRA |
9823109918
paragwatve@gmail.com |
| Dr Ashutosh Vatsyayan |
NEMCARE HOSPITAL |
G S ROAD BHANGAGARH GUWAHATI Kamrup Metropolitan Assam 781005 Kamrup ASSAM |
9878933112
ashutosh.vatsyayan@gmail.com |
| Dr M N Baruah |
North East Cancer Prevention Center |
11th Mile GS Rd Amerigog Jorabat Assam 781023 Kamrup ASSAM |
8486399973
drmuninbaruah@gmail.com |
| Dr Pratik Anand |
Savera Cancer & Multispeciality Hospital |
R N Singh Road Rajendra Ngara Overbridge Kankarbagh Patna 800020 Patna BIHAR |
9334159098
dranandpratik@gmail.com |
| Dr Sandeep Mithapara |
Swaminarayan Institute of Medical Sciences & Research |
Swaminarayan Institute of Medical Sciences & Research (SIMSR), Ahmedabad Mehsana Highway, At. & Po. Saij, Ta. Kalol, Dist. Gandhinagar, Gujarat 382725 Gandhinagar GUJARAT |
9510899993
skmithapara@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bharti Vidyapeeth Medical College & Hospital Sangli |
Approved |
| Institutional Ethics Committee of KLE Academy of Higher Education and Research |
Approved |
| Kolhapur Cancer Centre Institutional Ethics Committee |
Approved |
| Manavata Clinical Research Institute Ethics Committee |
Approved |
| Medilink Ethics Committee |
Approved |
| NEMCARE HOSPITALS ETHICS COMMITTEE |
Approved |
| Savera Cancer and Multispeciality Hospital - Institutional Ethics Committee |
Approved |
| The Institutional Ethics Committee of North East Cancer Hospital and Research Institute |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (3) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (4) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (5) ICD-10 Condition: C031||Malignant neoplasm of lower gum, (6) ICD-10 Condition: C004||Malignant neoplasm of lower lip, inner aspect, (7) ICD-10 Condition: C048||Malignant neoplasm of overlappingsites of floor of mouth, (8) ICD-10 Condition: C030||Malignant neoplasm of upper gum, (9) ICD-10 Condition: C003||Malignant neoplasm of upper lip, inner aspect, (10) ICD-10 Condition: C022||Malignant neoplasm of ventral surface of tongue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biopsy |
In this study an oral cavity examination will be done for the subjects and images of the oral cavity will be acquired. There is no drug or device intervention planned. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
A subject will be considered eligible in this study only if All of the following criteria apply:
1. Subject (or LAR) understands and agrees to comply with planned study procedures and provides informed consent before initiating study procedures.
2. Male or Female adults equal to or more than 18 to 65 years of age at the time of screening and enrolment.
3. Subject reporting to the site with at least one oral lesion. |
|
| ExclusionCriteria |
| Details |
A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
1. If the subject has participated in another clinical trial in the last 8 weeks before coming at Visit 1.
2. Subject having any other reason which may interfere with the study in the opinion of the Principal Investigator.
3. Subject is blind or falls under the category of vulnerable population. e.g., members of a group with hierarchical structure (e.g. prisoners armed forces personnel, staff and students of medical, nursing and pharmacy academic institutions), patients with incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority groups, homeless persons, nomads, refugees, minors or other incapable of personally giving consent.
4. Cancer subjects operated with reconstructive (flap) surgery.
5. If the subject’s mouth does not open wide enough for oral cavity examinations and image acquisition.
6. Subjects with unclear oral lesion images.
7. If according to the judgment of the investigator, subject needs more than 2 biopsy(ies) for assessment after signing informed consent and oral cavity examination.
8. Subjects for whom biopsy(ies) were done for the target lesion(s) more than 30 days from the date of consent.
9. If the subject has been operated for oral cancer / or any other oral mucosal lesions.
10. Pregnant or breast-feeding female subjects.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Performance metrics (Accuracy, Sensitivity, Specificity and F1 score). At Baseline & Week 2. |
Performance metrics (Accuracy, Sensitivity, Specificity and F1 score). At Baseline & Week 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="661" Sample Size from India="661"
Final Enrollment numbers achieved (Total)= "661"
Final Enrollment numbers achieved (India)="661" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
02/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tobacco usage in India is one of the largest preventable cause of non-communicable diseases such as oral cancer, lung cancer, obstructive lung disease and cardiovascular disease, to name a few. Consumption of tobacco in smoked forms (e.g., cigarettes, bidis, cigars, hookah) and smokeless forms (e.g., Gutkha, zarda, khaini) kills nearly a million users annually- all entirely preventable premature deaths. With nearly 300 million current users of risky tobacco in India, of which 200 million chew smokeless tobacco, the tobacco use epidemic and the resultant deaths from cancers and other preventable diseases are unlikely to abate for the foreseeable future. The effects of smokeless tobacco are most pronounced in the oral cavity, manifesting as submucosal fibrosis, leukoplakia and oral cancers. The incidence of oral cancer in India is among the highest worldwide, comprising nearly half of all oral cancers globally. Already, smokeless tobacco kills more than 350,000 people every year in India. Particularly concerning is the disproportionately higher use of smokeless tobacco among socio-economically disadvantaged groups, women and the rural population. For example, tobacco chewing is common among migrant construction workers, those living in urban slums, truck and metro transport drivers. In the case of pregnant women chewing tobacco, their tobacco use harms them as well as their babies with an increased risk of anaemia, higher rates of stillbirth and lower weight of the newborn. The user groups of smokeless tobacco often have a poor understanding of tobacco harms and cessation aids, along with poor access to healthcare. Cessation aids in the form of behavioural support and safer nicotine alternatives to smokeless tobacco are not affordable, accessible or available to the majority of the population. Screening for pre-malignant and early-stage oral cancers can be done by experts by visual inspection. However, if the person at the point of care (POC) who is screening is not skilled and experienced, then the sensitivity and specificity of the visual diagnosis can be very low. This is generally the case in rural healthcare settings. As a result, tobacco user patients from rural and disadvantaged backgrounds are more likely to present late with stage III or stage IV oral cancer. Currently in India, overall survival following treatment at 5 years for Stage I oral cancer is 100% and decreases to 85% for Stage II. For Stages III and IV, 5-year survival can be a mere 43% and 42% respectively. This is further worsened due to lower affordability and access to chemotherapy and radiotherapy for most of the rural populations. Early screening of pre-cancerous oral lesions such as Leukoplakia and Erythroplakia complemented by opportunistic and comprehensive tobacco cessation support has the potential to be a significant and impactful public health intervention. This is where ORAICLE believes that a well-designed, robustly tested and scientifically validated Artificial Intelligence (AI) algorithm can be a game-changer, and ORAICLE intends to develop an Artificial Intelligence Algorithm that can analyze images of the oral cavity at the POC and categorize the lesions as cancerous or non-cancerous and “red flag†them for further expert evaluation. |