| CTRI Number |
CTRI/2025/02/080778 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Utility of salivary Volatile organic compounds as a potential biomarker for early detection of Oral premalignant & malignant conditions |
|
Scientific Title of Study
|
Identification & Quantification of Salivary VOCs as a potential biomarker for the early detection of Oral Cancer and OPMD’s by Gas chromatography Mass spectrometry analysis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreekanth P Kunjumon |
| Designation |
Oral & Maxillofacial radiologist |
| Affiliation |
Department of Dentistry, Aster Hospital, Whitefield |
| Address |
Room no 6 , Ground Floor, A Block, Department of Dentistry Aster Whitefield hospital Plot No 3 & 4 Sadaramangala Industrial Area off Whitefield Main Road opposite ITPL Whitefield Bengaluru Karnataka 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
09035975973 |
| Fax |
|
| Email |
sreekanthpkunjumon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreekanth P Kunjumon |
| Designation |
Oral & Maxillofacial radiologist |
| Affiliation |
|
| Address |
Aster Whitefield hospital Plot No 3 & 4 Sadaramangala Industrial Area off Whitefield Main Road opposite ITPL Whitefield Bengaluru Karnataka 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
09035975973 |
| Fax |
|
| Email |
sreekanthpkunjumon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreekanth P Kunjumon |
| Designation |
Oral & Maxillofacial radiologist |
| Affiliation |
Department of Dentistry, Aster Hospital, Whitefield |
| Address |
Room no 6 , Ground Floor , A Block, Department of Dentistry, Aster Whitefield hospital Plot No 3 & 4 Sadaramangala Industrial Area off Whitefield Main Road opposite ITPL Whitefield Bengaluru Karnataka 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
09035975973 |
| Fax |
|
| Email |
sreekanthpkunjumon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aster Whitefield hospital Plot No 3 & 4 Sadaramangala Industrial Area off Whitefield Main Road opposite ITPL Whitefield Bengaluru Karnataka 560066, India |
|
|
Primary Sponsor
|
| Name |
Aster Whitefield Hospital |
| Address |
Plot No 3 & 4 Sadaramangala Industrial Area off Whitefield Main Road opposite ITPL Whitefield Bengaluru Karnataka 560066
Sadaramangala Industrial Area off Whitefield Main Road opposite ITPL Whitefield Bengaluru Karnataka 560066 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sreekanth P Kunjumon |
Aster whitefield hospital |
Room no 6, Ground Floor, A Block, Department of Dentistry ,Aster Whitefield hospital Plot No 3 & 4 Sadaramangala Industrial Area off Whitefield Main Road opposite ITPL Whitefield Bengaluru Karnataka 560066
Bangalore
KARNATAKA |
09035975973
sreekanthpkunjumon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aster ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy controls |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Minimum 20 year old patients with histopathological confirmation of Oral cancer and potentially premalignant lesions without any therapeutic interventions such as chemotherapy, radiotherapy, surgery or alternative remedies
Similarly, age and gender matched healthy subjects without history of hypertension, diabetes, hypothyroidism or any medication use during last 3 months
|
|
| ExclusionCriteria |
| Details |
Subjects with recurrent Oral Squamous Cell Carcinomas with metastasis in the head and neck region
Conditions that causes Xerostomia/dry mouth
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify volatile organic compounds which can be used as salivary biomarkers for early diagnosis of oral malignant and premalignant lesions |
3 months- Saliva collection and analysis
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Transition from laboratory to chairside diagnostics- Development of a portable sensor based device with high sensitivity and specificity for rapid clinical diagnosis with great potential for next generation screening tool for oral cancer detection and management |
3 months- Scientific writing and article publication
|
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Conventional visual and tactile examination (CVTE) is the most common method for the screening of Oral Cancer (OC) and Potentially premalignant oral epithelial lesions (PPOEL’s), however physicians need sufficient experience to ensure that the results of the CVTE are accurate. On the other hand, biopsy being the gold standard diagnostic confirmatory test, cannot be employed for screening mass population. Hence the identification of metabolic biomarkers in the saliva can potentially contribute in the development of a first of its kind point of care, non-invasive screening tool for OC’s. Due to its critical pathophysiology and the ubiquitous manifestations of metabolic effects of OC, the importance of Volatile organic compounds as biomarkers have been growing exponentially over the years. Saliva contains a range of analytes which can vary with high responsiveness representing a resourceful biofluid for systemic information. (Shigeyama et al 2018). Moreover, saliva being proximal fluid in OC reflects both physiological and pathophysiological state of the disease. Substantial gap exists in the use of salivary volatilome as a potential biomarker. This study is undertaken to identify & quantify OC induced metabolic adaptations via identifying changes in salivary VOCs using Gas chromatography- Mass spectrometry (GC-MS) analysis |