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

• Conditions: Oral Cancer; Oral Leukoplakia; Oral Lichen Planus; Premalignant Lesion
• Interventions: Diagnostic Test: Salivary Gamma-synuclein; Diagnostic Test: Incisional biopsy; Diagnostic Test: Conventional visual and tactile examination

• Registration Number: NCT04732741
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-01-27
• Last Update Submitted: 2021-01-27
• Study First Posted: 2021-02-01
• Last Update Posted: 2021-02-01
• Study Start: 2021-03-10
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral Cancer	Salivary Gamma-synuclein	patients diagnosed clinically and histopathologically with oral cancer who have yet to receive any treatment.
Oral Cancer	Incisional biopsy	patients diagnosed clinically and histopathologically with oral cancer who have yet to receive any treatment.
Oral Cancer	Conventional visual and tactile examination	patients diagnosed clinically and histopathologically with oral cancer who have yet to receive any treatment.
Premalignant lesions	Salivary Gamma-synuclein	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.
Premalignant lesions	Incisional biopsy	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.
Premalignant lesions	Conventional visual and tactile examination	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.
Control Group	Salivary Gamma-synuclein	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
Control Group	Conventional visual and tactile examination	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

Primary Outcome Measures

Name	Time	Method
Gamma-synuclein level sensitivity and specificity	At same time as biopsy	Measured using ELISA reader