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

NCT ID: NCT04732741

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-10

Study Completion Date

2021-12-10

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.

Detailed Description

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Conditions

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Oral Cancer Oral Lichen Planus Oral Leukoplakia Premalignant Lesion

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Oral Cancer

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

Salivary Gamma-synuclein

Intervention Type DIAGNOSTIC_TEST

Gamma-synuclein salivary levels measured using ELISA assay

Incisional biopsy

Intervention Type DIAGNOSTIC_TEST

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.

Conventional visual and tactile examination

Intervention Type DIAGNOSTIC_TEST

Conventional visual and tactile examination using light and mirror

Premalignant lesions

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.

Salivary Gamma-synuclein

Intervention Type DIAGNOSTIC_TEST

Gamma-synuclein salivary levels measured using ELISA assay

Incisional biopsy

Intervention Type DIAGNOSTIC_TEST

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.

Conventional visual and tactile examination

Intervention Type DIAGNOSTIC_TEST

Conventional visual and tactile examination using light and mirror

Control Group

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

Salivary Gamma-synuclein

Intervention Type DIAGNOSTIC_TEST

Gamma-synuclein salivary levels measured using ELISA assay

Conventional visual and tactile examination

Intervention Type DIAGNOSTIC_TEST

Conventional visual and tactile examination using light and mirror

Interventions

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Salivary Gamma-synuclein

Gamma-synuclein salivary levels measured using ELISA assay

Intervention Type DIAGNOSTIC_TEST

Incisional biopsy

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.

Intervention Type DIAGNOSTIC_TEST

Conventional visual and tactile examination

Conventional visual and tactile examination using light and mirror

Intervention Type DIAGNOSTIC_TEST

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

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Salma mohamed saad-eldin mahmoud

Resident at the faculty of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Fat'heya Zahran

Role: CONTACT

01060775113

Noha Azab

Role: CONTACT

01001381954

Other Identifiers

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SS2021

Identifier Type: -

Identifier Source: org_study_id

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