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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04732741
Other study ID # SS2021
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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: -

Study Design


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
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