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

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ClinicalTrials.gov Identifier: NCT04732741

Recruitment Status : Not yet recruiting

First Posted : February 1, 2021

Last Update Posted : February 1, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Salma mohamed saad-eldin mahmoud, Cairo University

Study Description

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.

Condition or disease	Intervention/treatment
Oral Cancer Oral Lichen Planus Oral Leukoplakia Premalignant Lesion	Diagnostic Test: Salivary Gamma-synuclein Diagnostic Test: Incisional biopsy Diagnostic Test: Conventional visual and tactile examination

Study Design

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Study Type :	Observational
Estimated Enrollment :	69 participants
Observational Model:	Other
Time Perspective:	Cross-Sectional
Official Title:	Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions
Estimated Study Start Date :	March 10, 2021
Estimated Primary Completion Date :	December 10, 2021
Estimated Study Completion Date :	December 10, 2021

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Leukoplakia Oral Cancer Oral Leukoplakia Lip and Oral Cavity Cancer

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Oral Cancer patients diagnosed clinically and histopathologically with oral cancer who have yet to receive any treatment.	Diagnostic Test: Salivary Gamma-synuclein Gamma-synuclein salivary levels measured using ELISA assay Diagnostic Test: 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. Diagnostic Test: 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.	Diagnostic Test: Salivary Gamma-synuclein Gamma-synuclein salivary levels measured using ELISA assay Diagnostic Test: 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. Diagnostic Test: 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	Diagnostic Test: Salivary Gamma-synuclein Gamma-synuclein salivary levels measured using ELISA assay Diagnostic Test: Conventional visual and tactile examination Conventional visual and tactile examination using light and mirror

Outcome Measures

Primary Outcome Measures :

Gamma-synuclein level sensitivity and specificity [ Time Frame: At same time as biopsy ]
Measured using ELISA reader

Biospecimen Retention: Samples With DNA

Salivary sample

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732741

Contacts

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Contact: Fat'heya Zahran	01060775113	fatheya.zahran@dentistry.cu.edu.eg
Contact: Noha Azab	01001381954	noha.adel@dentistry.cu.edu.eg

Sponsors and Collaborators

Cairo University

More Information

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Responsible Party:	Salma mohamed saad-eldin mahmoud, Resident at the faculty of Dentistry, Cairo University
ClinicalTrials.gov Identifier:	NCT04732741
Other Study ID Numbers:	SS2021
First Posted:	February 1, 2021 Key Record Dates
Last Update Posted:	February 1, 2021
Last Verified:	January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Mouth Neoplasms Precancerous Conditions Leukoplakia Leukoplakia, Oral Lichen Planus, Oral Lichen Planus Head and Neck Neoplasms Neoplasms by Site	Neoplasms Mouth Diseases Stomatognathic Diseases Lichenoid Eruptions Skin Diseases, Papulosquamous Skin Diseases Pathological Conditions, Anatomical

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