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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salivary Gamma-synuclein | Diagnostic Test | Gamma-synuclein salivary levels measured using ELISA assay |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gamma-synuclein level sensitivity and specificity | Measured using ELISA reader | At same time as biopsy |
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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:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fat'heya Zahran | Contact | 01060775113 | fatheya.zahran@dentistry.cu.edu.eg | |
| Noha Azab | Contact | 01001381954 | noha.adel@dentistry.cu.edu.eg |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D017676 | Lichen Planus, Oral |
| D007972 | Leukoplakia, Oral |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
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Salivary sample
| Incisional biopsy | 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 | Diagnostic Test | Conventional visual and tactile examination using light and mirror |
|
| D009057 |
| Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007971 | Leukoplakia |
| D011230 | Precancerous Conditions |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |