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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04732741
Enrollment
69
Registered
2021-02-01
Start date
2021-03-10
Completion date
2021-12-10
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cancer, Oral Lichen Planus, Oral Leukoplakia, Premalignant Lesion

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.

Interventions

DIAGNOSTIC_TESTSalivary Gamma-synuclein

Gamma-synuclein salivary levels measured using ELISA assay

DIAGNOSTIC_TESTIncisional 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_TESTConventional visual and tactile examination

Conventional visual and tactile examination using light and mirror

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Gamma-synuclein level sensitivity and specificityAt same time as biopsyMeasured using ELISA reader

Contacts

Primary ContactFat'heya Zahran
fatheya.zahran@dentistry.cu.edu.eg01060775113
Backup ContactNoha Azab
noha.adel@dentistry.cu.edu.eg01001381954

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026