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CTRI Number  CTRI/2024/11/076603 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Screening of Tobacco users by AI Mobile App for the early detection of oral PMDs & oral cancer 
Study Design  Single Arm Study 
Public Title of Study   Screening of Tobacco consuming participants using an artificial intelligence-based mobile application for the early detection of oral potentially malignant disorders and oral cancer & referral to designated health care centers. 
Scientific Title of Study   Screening of Tobacco users using artificial intelligence-based mobile application for the early detection & referral of oral potentially malignant disorders (OPMDs) and oral cancer to designated health care centres. 
Trial Acronym  Screening of Tobacco users using artificial intelligence-based mobile application 
Secondary IDs if Any  
Secondary ID  Identifier 
V1.0 Dated 20 Sep 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakesh Neve 
Designation  Directos 
Affiliation  Life Point Hospital 
Address  Life Point Hospital, Bypass Road Mumbai Pune Express Highway, Near Sayaji Hotel Wakad Pune

Pune
MAHARASHTRA
411057
India 
Phone  9881143140  
Fax    
Email  rakesh.neve23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gaurav Kale 
Designation  Oral Health Expert  
Affiliation  Oraicle Biosciences Limited 
Address  104 Anupam Homes, Kshirsagar Colony Hirawadi Road Near Dave Farshan, Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  8355906632  
Fax    
Email  gaurav@oraiclebio.com  
 
Details of Contact Person
Public Query
 
Name  Mr Ayan Neogi 
Designation  Managing Director 
Affiliation  Vivforever Aesthetics Private Limited 
Address  103 A Doordarshan CHS Gokuldham Goregaon East Mumbai

Mumbai (Suburban)
MAHARASHTRA
400063
India 
Phone  9967968612  
Fax    
Email  ayanneogi@vivforever.in  
 
Source of Monetary or Material Support  
Oraicle Biosciences Limited 
 
Primary Sponsor  
Name  Oraicle Biosciences Limited  
Address  Unit C, Anchor House, School Lane, Chandlers Ford, Eastleigh SO53 4DY, UNITED KINGDOM  
Type of Sponsor  Research institution 
 
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
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
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
Belgaum
KARNATAKA 
9880845530

punnyasanjay@gmail.com 
Dr Parag Watve  Kolhapur Cancer Centre Pvt Ltd   Head & Neck Cancer Department, A/p. R. S. No. 238, opp. Mayur Petrol Pump, Gokul Shirgaon, Maharashtra 416234 Kolhapur MAHARASHTRA
Kolhapur
MAHARASHTRA 
9823109918

paragwatve@gmail.com 
Dr Rakesh Neve  Life Point Hospital  No 145 Sr Multispecialist hospital in PCMC 1 Mumbai Pune Bypass Rd Flyover near Sayaji Hotel, Shankar Kalat Nagar Wakad Pimpri-Chinchwad Pune Maharashtra 411057
Pune
MAHARASHTRA 
9881143140

akesh.neve23@gmail.com 
Dr M N Baruah   North East Cancer Prevention Centre   11th Mile, Jorabat, Guwahati-781023, Assam, India Kamrup ASSAM
Kamrup
ASSAM 
8486399973

munin_b@hotmail.com 
Dr Harish Saluja  Pravara Institute Of Medical Science   Department of Oral & Maxillofacial Surgery, Loni, Taluka Rahata, District Ahmednagar 413736 Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 
9766921178

harry_saluja@yahoo.co.in 
Dr Pratik Anand  Savera Cancer & Multispeciality Hospital  R N Singh Road Rajendra Ngara Overbridge Kankarbagh Patna 800020 Patna BIHAR
Patna
BIHAR 
9334159098

dranandpratik@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 
Lifepoint Research - Ethics Committee   Approved 
Manavata Clinical Research Institute Ethics Committee   Approved 
Pravara Institute of Medical Sciences  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: C049||Malignant neoplasm of floor of mouth, unspecified, (3) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (4) ICD-10 Condition: C005||Malignant neoplasm of lip, unspecified, inner aspect, (5) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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. Subjects with 1 or more than 1 year tobacco consumption history. 
 
ExclusionCriteria 
Details  A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:

1.Subject having any other reason which may interfere with the study in the opinion of the Principal Investigator.
2.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.
3.Cancer subjects operated with reconstructive (flap) surgery.
4.Subject with pre diagnosed lesion and under treatment or evaluation

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 the subject has been operated for oral cancer/ or any other oral mucosal lesions.
8.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 
To screen tobacco users using artificial intelligence-based mobile application for detection and referral of the suspected potentially malignant and cancerous lesions to the designated health care centres.  At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1.To categorize the screened lesions as non-cancerous, potentially malignant disorders and cancerous as detected by AI based mobile application.
2.To evaluate the sensitivity of AI based mobile application detecting potentially malignant disorders or cancerous lesions using the opinion of the Trained Clinicians.
3.To collect and analyse feedback of the Research team on the utility of AI based mobile application in terms of user friendliness, challenges if any.
 
At Baseline & Day 3 
 
Target Sample Size   Total Sample Size="10500"
Sample Size from India="10500" 
Final Enrollment numbers achieved (Total)= "10500"
Final Enrollment numbers achieved (India)="6026" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/11/2024 
Date of Study Completion (India) 12/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

“Every year, nearly a million people succumb to premature deaths that could be prevented, attributable to the consumption of smoked tobacco products like cigarettes, bidis, cigars, and hookah, along with smokeless varieties such as Gutkha, zarda, and khaini.   In India, where around 300 million people currently use hazardous tobacco products, including 200 million who consume smokeless tobacco, reducing tobacco consumption and the consequent fatalities from cancers and other preventable illnesses continues to be a top public health concern. The impact of smokeless tobacco is most evident in the oral cavity, leading to conditions such as submucosal fibrosis, leukoplakia, and oral cancers.

Oral cancer is a significant global health burden, with an estimated 377,713 new cases and 177,757 deaths worldwide in 2020 alone. Oral potentially malignant disorders (OPMDs) are a set of disorders that exhibit an increased risk of malignant transformation. These lesions present an array of clinical variations, including white, red, or mixed red-white lesions with verrucous, papillary, corrugated, atrophic, and ulcerated presentations. In addition, lesions like frictional keratosis, chemical injury, leukoedema, candidiasis, denture-associated stomatitis, and desquamative or autoimmune disorders exhibit overlapping clinical features, making the diagnosis of OPMDs challenging. Though oral cancers can develop de novo, OPMDs share numerous risk factors and molecular/genetic alterations with oral cancers. Studies indicate that most habit-associated oral cancers evolve from pre-existing OPMDs. Preliminary epidemiological research and systematic reviews report that 0.1 to 40% of leukoplakia develops into oral cancer. Hence, the early diagnosis and differentiation of OPMDs from clinically similar-appearing lesions are vital for limiting the possible malignant change and improving treatment outcomes.

 â€œPatients exhibiting oral lesions frequently have their initial consultations with general practitioners (GPs), both in medical and dental fields. This places GPs in a critical position to identify oral cancer in its early stages. However, research has highlighted a concerning gap in GPs’ knowledge and awareness regarding oral cancer diagnosis, particularly in recognizing its early signs. This lack of awareness is a major factor contributing to delayed referrals and treatment of oral cancer. A delay in diagnosis can lead to the need for more invasive treatments, significantly increasing the morbidity of oral functions such as speech, chewing, and swallowing. This not only affects the physical health of the patient but also profoundly impacts their quality of life”.

“The oral cavity is more readily accessible for examination without specialized instruments compared to other internal organs. A Conventional Oral Examination (COE), which includes a visual inspection by a healthcare professional, is the standard approach for identifying oral lesions. While clinical evaluation of oral potentially malignant diseases (OPMDs) is based on subjective assessment, biopsies are considered the definitive method for accurate diagnosis. However, in many low- and middle-income countries, access to specialists and adequate healthcare services is limited, leading to delayed diagnosis and referral for patients with OPMDs and oral cancer. On the other hand, while biopsy-based diagnoses are considered definitive, they are not ideal for large-scale screening due to their invasive nature, the requirement for expert analysis, and limited availability in point-of-care or remote areas. Additionally, biopsy diagnoses are subject to interpretive variability and inconsistencies, which can affect the objectivity of the results. Hence, it is crucial to create user-friendly, non-invasive oral screening tools that can augment the current system, offering more precise, rapid, and standardized diagnoses to enhance survival rates for oral cancer patients”.

Advances in artificial intelligence (AI) have introduced new possibilities for enhancing the accuracy and efficiency of medical diagnoses, including the early detection of oral cancer. AI-based tools, particularly those employing machine learning algorithms, have shown promise in analyzing medical images, identifying patterns, and predicting the presence of malignant and premalignant lesions with high precision.

 
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