Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions

Study Overview
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Brief Summary
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Synucleins are a family of small, highly conserved proteins found in vertebrates and are specially abundant in neurons particularly in presynaptic terminals (Surguchov et al., 2001). Gamma-synuclein is the third member of the synuclein family, and is predominantly found in the cytosol of tumor cells and functions both intra- and extra-cellularly. It is involved in the pathogenesis of different types of cancer and some neurodegenerative diseases (Liu et al., 2018). Smoking - a major risk factor for oral cancer and its progression - and nicotine-containing products were found to time-dependently up-regulate the Gamma-synuclein expression in cancer cells (Hsu et al., 2020a). Gamma-synuclein is released from tumor cells and was found to be elevated in tumors such as urinary bladder cancer (Liu et al., 2016), colorectal cancer, gastric adenocarcinomas and esophageal cancer (Liu et al., 2012). It is present in blood, serum, cerebrospinal fluid and saliva. The detection of extracellular synucleins in body fluids can reveal the first steps of the disease thus it can be used as a potential tool for early cancer detection (Surguchov, 2016). This study aims to identify the diagnostic accuracy of Gamma-synuclein in differentiating between oral malignant lesions and oral premalignant lesions.

Official Title
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Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions

Conditions
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Oral Cancer, Oral Lichen Planus, Oral Leukoplakia, Premalignant Lesion

Intervention / Treatment
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* Diagnostic Test: Salivary Gamma-synuclein
* Diagnostic Test: Incisional biopsy
* Diagnostic Test: Conventional visual and tactile examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1: patients with malignant lesions will be diagnosed through clinical and histopathological examination of tissue biopsy. Group 2: patients with oral potentially malignant lesions will be diagnosed clinically and histopathological examination of tissue biopsy. Group 3: healthy individuals who will be examined clinically through conventional visual and tactile examination to ensure no oral lesions are present and through thorough medical history Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral Cancer<br>patients diagnosed clinically and histopathologically with oral cancer who have yet to receive any treatment. | Diagnostic Test: Salivary Gamma-synuclein<br>* Gamma-synuclein salivary levels measured using ELISA assay<br>Diagnostic Test: Incisional biopsy<br>* A) Biopsy (reference standard): biopsy for group 1 will be performed by specialists in the national cancer institute. B) Biopsy for oral potentially malignant lesions will be performed by the candidate from the most representative region.<br>Diagnostic Test: Conventional visual and tactile examination<br>* Conventional visual and tactile examination using light and mirror<br>|
| Premalignant lesions<br>patients diagnosed clinically and histopathologically with oral potentially malignant lesions who have not yet to receive treatment or had a month wash-out period from any previous treatment. | Diagnostic Test: Salivary Gamma-synuclein<br>* Gamma-synuclein salivary levels measured using ELISA assay<br>Diagnostic Test: Incisional biopsy<br>* A) Biopsy (reference standard): biopsy for group 1 will be performed by specialists in the national cancer institute. B) Biopsy for oral potentially malignant lesions will be performed by the candidate from the most representative region.<br>Diagnostic Test: Conventional visual and tactile examination<br>* Conventional visual and tactile examination using light and mirror<br>|
| Control Group<br>healthy individuals who will be examined clinically through conventional visual and tactile examination to ensure no oral lesions are present and through thorough medical history | Diagnostic Test: Salivary Gamma-synuclein<br>* Gamma-synuclein salivary levels measured using ELISA assay<br>Diagnostic Test: Conventional visual and tactile examination<br>* Conventional visual and tactile examination using light and mirror<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gamma-synuclein level sensitivity and specificity | Measured using ELISA reader | At same time as biopsy |