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

Cairo University (CU)

Status: Unknown

Conditions: Oral Lichen Planus; Oral Cancer; Premalignant Lesion; Oral Leukoplakia

Treatments: Diagnostic Test: Salivary Gamma-synuclein; Diagnostic Test: Incisional biopsy; Diagnostic Test: Conventional visual and tactile examination

Study type: Observational

Funder types: Other

Identifiers

NCT04732741

SS2021

Details and patient eligibility

About

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.

Enrollment: 69 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

69 participants in 3 patient groups

Oral Cancer

Description:

patients diagnosed clinically and histopathologically with oral cancer who have yet to receive any treatment.

Treatment:

Diagnostic Test: Salivary Gamma-synuclein

Diagnostic Test: Incisional biopsy

Diagnostic Test: Conventional visual and tactile examination

Premalignant lesions

Description:

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.

Treatment:

Diagnostic Test: Salivary Gamma-synuclein

Diagnostic Test: Incisional biopsy

Diagnostic Test: Conventional visual and tactile examination

Control Group

Description:

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

Treatment:

Diagnostic Test: Salivary Gamma-synuclein

Diagnostic Test: Conventional visual and tactile examination