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

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Tongue neoplasm
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Brief Title

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

Official Title

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

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.

Study Type

Observational

Primary Outcome

Gamma-synuclein level sensitivity and specificity

Condition

Oral Cancer

Intervention

Salivary Gamma-synuclein

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

69

Start Date

March 10, 2021

Completion Date

December 10, 2021

Primary Completion Date

December 10, 2021

Eligibility Criteria

        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

All

Ages

20 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, 01060775113, [email protected]

Administrative Informations

NCT ID

NCT04732741

Organization ID

SS2021

Responsible Party

Principal Investigator

Study Sponsor

Cairo University

Study Sponsor

, ,

Verification Date

January 2021