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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 10, 2021

Interventions

  • Diagnostic Test: Salivary Gamma-synuclein
    • Gamma-synuclein salivary levels measured using ELISA assay
  • 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.
  • Diagnostic Test: Conventional visual and tactile examination
    • Conventional visual and tactile examination using light and mirror

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Gamma-synuclein level sensitivity and specificity
    • Time Frame: At same time as biopsy
    • Measured using ELISA reader

Participating in This Clinical Trial

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:

-

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Salma mohamed saad-eldin mahmoud, Resident at the faculty of Dentistry – Cairo University
  • Overall Contact(s)
    • Fat’heya Zahran, 01060775113, fatheya.zahran@dentistry.cu.edu.eg

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