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 Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- To identify volatile organic compounds which can be used as salivary biomarkers for early diagnosis of oral malignant and premalignant lesions
Study Overview
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
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 20.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Subjects with recurrent Oral Squamous Cell Carcinomas with metastasis in the head and neck region Conditions that causes Xerostomia/dry mouth.
Outcomes
Primary Outcomes
To identify volatile organic compounds which can be used as salivary biomarkers for early diagnosis of oral malignant and premalignant lesions
Time Frame: 3 months- Saliva collection and analysis
Secondary Outcomes
- • 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)
Investigators
Dr Sreekanth P Kunjumon
Department of Dentistry, Aster Hospital, Whitefield