| CTRI Number |
CTRI/2022/05/042447 [Registered on: 11/05/2022] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Open Label |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to collect images from oral cavity of participating subjects to build an artificial intelligence-based tool 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 build an artificial intelligence-based tool 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 Unmesh Takalkar |
| Designation |
Chief Managing Director |
| Affiliation |
United CIIGMA Institute of Medical Sciences |
| Address |
United CIIGMA Institute of Medical Sciences Pvt. Ltd
plot No.617 Survey No. 10, Shahanoorwadi, Dargah Road, Aurangabad- 431005, Maharashtra,India
Aurangabad MAHARASHTRA 431005 India |
| Phone |
9822042425 |
| Fax |
|
| Email |
takalkar.unmesh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mr Ayan Neogi |
| Designation |
Managing Director |
| Affiliation |
Vivforever Aesthetics Private Limited |
| Address |
103 A, Bhairavi, Doordarshan CHS, Gokuldham, Goregaon East, Mumbai 400063, Maharashtra, India
Mumbai MAHARASHTRA 400063 India |
| Phone |
9967968612 |
| Fax |
|
| Email |
ayanneogi@gmail.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 400063, Maharashtra, India
MAHARASHTRA 400063 India |
| Phone |
9967968612 |
| Fax |
|
| Email |
ayanneogi@gmail.com |
|
|
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
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uma Datar |
Bharati Vidyapeeth Medical College & Hospital, |
Sangli – Miraj
Road, Wanalesawadi, Sangli, Maharashtra – 416416, Sangli MAHARASHTRA |
9595624566
dataruv@gmail.com |
| Dr Nitin Bhola |
Datta Meghe Institute of Medical Sciences |
Department of Head & Neck Cancers, Sawangi (Meghe), Wardha, Maharashtra 442004 Wardha MAHARASHTRA |
9970070607
drnitinbhola@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 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 |
9823109918
paragwatve@gmail.com |
| Dr M N Baruah |
North East Cancer Prevention Centre |
11th Mile, Jorabat, Guwahati-781023, Assam, India Kamrup ASSAM |
8486399973
munin_b@hotmail.com |
| Dr Tanvy Subir Sansgiri |
Pravara Institute Of Medical Science |
Department of Oral & Maxillofacial Surgery, Loni, Taluka Rahata, District Ahmednagar 413736 Ahmadnagar MAHARASHTRA |
9158209628
tanvy2192@gmail.com |
| Dr Rajesh Padhy |
Sparsh Hospital & Critical Care Pvt Ltd |
Department of Oral Cancer, Plot No A/407 Sahidnagar, Bhubaneswar 751007 Khordha ORISSA |
9437166120
drrajeshkumarpadhy@gmail.com |
| Dr Unmesh Takalkar |
United CIIGMA Institute of Medical Sciences Pvt Ltd |
Department of Oral Cancer & Clinical Research Unit 6th Floor, Plot No.6/7 Survey No. 10, Shahnoorwadi, Dargah Road, Aurangabad- 431005, Maharashtra,India Aurangabad MAHARASHTRA |
9822042425
takalkar.unmesh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 18 |
| Name of Committee |
Approval Status |
| Ethics Committee Group of CIIGMA Hospital |
Approved |
| Goenka Research Institute of Dental Science |
Approved |
| Health Point Ethics Committee Kolkata |
Approved |
| Health Point Ranchi Ethics Committee |
Approved |
| Institutional Ethical Committee Government Medical College Srinagar |
Approved |
| Institutional Ethics Committee Bharti Vidyapeeth Medical College & Hospital Sangli |
Approved |
| Institutional Ethics Committee Datta Meghe Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee KIMS-ICON Hospital |
Approved |
| Institutional Ethics Committee of KLE Academy of Higher Education and Research |
Approved |
| Institutional Ethics Committee Rungta College of Dental Sciences and Research |
Approved |
| Institutional Ethics Committee Sparsh Hospital & Critical Care Pvt Ltd |
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 |
| Shifa 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: C00||Malignant neoplasm of lip, (5) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (6) ICD-10 Condition: C02||Malignant neoplasm of other and unspecified parts of tongue, (7) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (8) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply:
1. Subject (or legally acceptable representative) understands and agrees to comply with planned study procedures and provides informed consent prior to initiation of study procedures
2. Male & Female adults ≥18 to < 65 years of age at the time of screening & enrolment.
3. Subject reporting to the site with some kind of oral lesions.
|
|
| 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. If the subject’s mouth does not open wide enough for oral cavity examinations and image acquisition.
5. If according to the judgment of the investigator Subject needs more than 2 biopsy(ies) for assessment after informed consent and oral cavity examination
6. Subjects for whom biopsy(ies) were done for the target lesion(s) more than 60 days from the date of consent.
7. Pregnant or breastfeeding female subjects.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To validate the Artificial Intelligence (AI) algorithm by comparing the output of the algorithm on category of the lesions and the diagnosis of the same images made by investigator capturing the images at the site. |
Screening Visit, Visit 1 and Visit 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="3000" Sample Size from India="3000"
Final Enrollment numbers achieved (Total)= "3000"
Final Enrollment numbers achieved (India)="3000" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
13/05/2022 |
| Date of Study Completion (India) |
30/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" 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. |