| 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
|
|
|
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
|
|
|
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
|
|
|
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. “Patients 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 lifeâ€. “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 patientsâ€. 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. |