Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions
NCT ID: NCT04732741
Last Updated: 2021-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
69 participants
OBSERVATIONAL
2021-03-10
2021-12-10
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Oral Cancer
patients diagnosed clinically and histopathologically with oral cancer who have yet to receive any treatment.
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
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.
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
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
Salivary Gamma-synuclein
Gamma-synuclein salivary levels measured using ELISA assay
Conventional visual and tactile examination
Conventional visual and tactile examination using light and mirror
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
20 Years
80 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Salma mohamed saad-eldin mahmoud
Resident at the faculty of Dentistry
Central Contacts
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Other Identifiers
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SS2021
Identifier Type: -
Identifier Source: org_study_id
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