| CTRI Number |
CTRI/2024/07/071091 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Screening of Oral Cancer using LED based device |
|
Scientific Title of Study
|
Design, Assembly, Testing, and Multi-Center
Evaluation of a Miniature and Portable LIF
System for Screening of Oral Malignancy. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vineetha R |
| Designation |
Professor and Head |
| Affiliation |
Manipal College of Dental Sciences, Manipal, MAHE |
| Address |
Professor and Head, Oral Medicine and Radiology, Manipal College of Dental Sciences,MAHE, Manipal
Manipal Academy of Higher Education, Manipal, Udupi District
Udupi
KARNATAKA
576104
India |
| Phone |
9964896254 |
| Fax |
|
| Email |
vineetha.manu@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jijo Lukose |
| Designation |
Assistant Professor |
| Affiliation |
Department of Atomic and Molecular Physics,, Manipal, MAHE |
| Address |
Dept of Atomic and Molecular Physics,MIT, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310284970 |
| Fax |
|
| Email |
jijolks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jijo Lukose |
| Designation |
Assistant Professor |
| Affiliation |
Department of Atomic and Molecular Physics,, Manipal, MAHE |
| Address |
Dept of Atomic and Molecular Physics,MIT, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310284970 |
| Fax |
|
| Email |
jijolks@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of science and technology,Governmnet of INDIA funded project |
|
|
Primary Sponsor
|
| Name |
Department of science and technology,Governmnet of INDIA |
| Address |
Department of Science & Technology, Technology Bhavan, New Mehrauli Road,, New Delhi-110 016. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramprasad VP |
,Dr.TMA Pai Hospital,Udupi |
Department of Public Health Dentistry,Urban centre Dental clinic-first floor, 8PCQ+MRP, NH 66, Kinnimulki, Udupi, Karnataka 576101
Udupi
KARNATAKA |
9845100424
vasthare.ram@manipal.edu |
| DrRavikiran Ongole |
Manipal College of Dental Sciences, Mangalore |
Dental OPD-Room No.1, Kasturba Medical College, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka 575001
Dakshina Kannada
KARNATAKA |
9448430387
ravikiran.ongole@manipal.edu |
| Dr Vineetha R |
Manipal College of Dental Sciences, Manipal |
Dental OPD-Room No. 1, 9Q3R+J2R, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9964896254
vineetha.manu@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: C049||Malignant neoplasm of floor of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Collection of fluorescence spectra from oral cavity. |
Using LED as a source fluorescence will be collected from the suspicious lesions of oral cavity. The collection of spectra from each site will take 4-5 seconds only. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cases
1. Patients diagnosed clinically with oral cancer or potentially malignant oral lesions (Leukoplakia/erythroplakia)
2. Presence of oral lesions suspected to be malignant or potentially malignant and requiring tissue biopsy.
3.No oral cancer surgery, chemotherapy or radiotherapy, or recurrences.
Control:
1. patients undergoing excision of clinically benign oral soft tissue (as in pericoronal flap excision/ gingival overgrowth excision).
2. Absence of oral lesions suspected to be malignant or potentially malignant but requiring surgical excision of oral tissue as mentioned above.
3.No medical contraindication for oral soft tissue excision. |
|
| ExclusionCriteria |
| Details |
Cases
1. Patients diagnosed clinically with oral cancer or potentially malignant oral lesions (Leukoplakia/erythroplakia)
2. Presence of oral lesions suspected to be malignant or potentially malignant and requiring tissue biopsy.
3.No oral cancer surgery, chemotherapy or radiotherapy, or recurrences.
Control:
1. patients undergoing excision of clinically benign oral soft tissue (as in pericoronal flap excision/ gingival overgrowth excision).
2. Absence of oral lesions suspected to be malignant or potentially malignant but requiring surgical excision of oral tissue as mentioned above.
3.No medical contraindication for oral soft tissue excision. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A handheld LED based optical device for the Screening of Oral
Malignancy. |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This device can be utilized to screen the other epithelial cancers such as cervical cancer. |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The spectroscopic techniques are emerging as an effective tool for the detection of cancers in an effective way. This technique has the potential to be used as an alternative to biopsy which is called optical biopsy. This Multi center intervention study mainly aims at the development of a compact device that is capable of acting like an optical biopsy device for oral cancer screening. |