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CTRI Number  CTRI/2020/01/022999 [Registered on: 27/01/2020] Trial Registered Prospectively
Last Modified On: 16/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Screening
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Usefulness of newly developed light emitting device for screening of precancer and cancer 
Scientific Title of Study   Validation of novel light emitting device for screening of potential malignant oral disorders and oral cancer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Keerthilatha M Pai 
Designation  Professor and Dean 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room number 1, Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845637938  
Fax    
Email  keerthilatha.pai@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Keerthilatha M Pai 
Designation  Professor and Dean 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room number 1, Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal


KARNATAKA
576104
India 
Phone  9845637938  
Fax    
Email  keerthilatha.pai@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Keerthilatha M Pai 
Designation  Professor and Dean 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room number 1, Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal


KARNATAKA
576104
India 
Phone  9845637938  
Fax    
Email  keerthilatha.pai@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Dental Sciences, Manipal 
 
Primary Sponsor  
Name  Keerthilatha M Pai 
Address  Room number 1, Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Vitrix Health systems  Vitrix Health systems, 50E, 98th street, Appartment 7B-4, New York, NY, 10029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Keerthilatha M Pai  Manipal College of Dental Sciences, Manipal  Room number 1, Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA 
9845637938

keerthilatha.pai@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K134||Granuloma and granuloma-like lesions of oral mucosa, (2) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue, (3) ICD-10 Condition: K135||Oral submucous fibrosis, (4) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  A light emitting device is used to capture pictures of the oral cavity under UV, white light and narrow band light of the various areas of interest. This would be followed by biopsy and suture placement. 
Intervention  potential malignant oral disorders and oral cancer group  A light emitting device is used to capture pictures of the oral cavity under UV, white light and narrow band light of the various areas of interest. This would be followed by biopsy and suture placement.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Potential malignant oral disorders and oral cancer group: Patients with potential malignant oral disorders and oral cancer
Controls: Patients other than potential malignant oral disorders and oral cancer requiring any type of biopsy in the oral cavity. 
 
ExclusionCriteria 
Details  Exclusion Criteria: Subjects with minimal comprehension, not willing for biopsy, any medical condition that contraindicates the use of biopsy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reliability and validity of the light emitting device in comparison to biopsy  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
sensitivity, specificity, negative and positive predictive values  1 week 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Oral cancer is an emerging epidemic which is amenable for screening with minimal resource. It is the third most common cancer affecting Indian males.  Early detection of oral cancer can improve the five year survival rate, reduce the morbidity associated with treatment and also prevent recurrence to 10–20%. Oral cancer is often preceded by dysplastic oral mucosal conditions which have potential for malignant transformation.  Conventionally, the diagnosis is done by histopathologic evaluation of biopsy specimen which is invasive and causes severe patient discomfort. Hence it cannot be done as a routine screening test and is advised only when there is a strong clinical suspicion of malignant transformation. Non-invasive screening modalities for early identification of the cancer and oral dysplastic conditions are the need of the hour.  Novel light emitting device under study is a non -invasive, user friendly, low cost device which aims to guide the clinicians in assessing the early dysplastic oral mucosal areas. If tested useful and effective, this device can be a useful adjunct in screening the general population, especially the high risk category, on a regular basis. As it is non-invasive, it is more patient compliant and can be helpful in patient education as well.  The present study intends to test the reliability and validity of a  novel non-invasive screening tool for oral cancer.

Subjects will be screened in the department of oral medicine and radiology and eligible participants would be enrolled into the trial. Only conditions which have biopsy as a standard of care would be recruited in the study and control group. After the consent, the participant would be evaluated with the help of novel light emitting device and pictures of the oral cavity would be captured under UV, white light and narrow band light of the various areas of interest. This would be followed by biopsy and suture placement. A brief history which included age, gender, patients habits if any, frequency and duration, and symptoms will also be recorded. Based on the biopsy report, patients will be counseled by the clinicians as and when required for further modalities of treatment.

 
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