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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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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.
 
 
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. 

 
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