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
|
|
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. |