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
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Verification Date
January 2021