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

Oral Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04732741
• Other study ID #: SS2021
• Status: Not yet recruiting
• Start date: March 10, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: Fat'heya Zahran
• Phone: 01060775113
• Email: fatheya.zahran[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 69
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Leukoplakia
• Leukoplakia, Oral
• Lichen Planus
• Lichen Planus, Oral
• Mouth Neoplasms
• Oral Cancer
• Oral Leukoplakia
• Oral Lichen Planus
• Precancerous Conditions
• Premalignant Lesion

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gamma-synuclein level sensitivity and specificity	Measured using ELISA reader	At same time as biopsy