Oral CancerNCT04732741
Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions
An observational study of Oral Cancer and Oral Lichen Planus, run by Cairo University.
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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Oral Cancer, Oral Lichen Planus, Oral Leukoplakia
- What is being tested?
- Salivary Gamma-synuclein, Incisional biopsy and Conventional visual and tactile examination
- Type of treatment
- Pill or oral medicine
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2021to 10 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Oral Cancer, Oral Lichen Planus, Oral Leukoplakia, Premalignant Lesion
- Being tested
- Salivary Gamma-synuclein, Incisional biopsy, Conventional visual and tactile examination
- Medical subject headings
- Mouth Neoplasms, Lichen Planus, Oral, Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary Gamma-synucleinDiagnostic test
Gamma-synuclein salivary levels measured using ELISA assay
Incisional biopsyDiagnostic test
- Biopsy (reference standard): biopsy for group 1 will be performed by specialists in the national cancer institute.
- Biopsy for oral potentially malignant lesions will be performed by the candidate from the most representative region.
Conventional visual and tactile examinationDiagnostic test
Conventional visual and tactile examination using light and mirror
| Study group | Role | What they receive |
|---|---|---|
| Oral Cancer | patients diagnosed clinically and histopathologically with oral cancer who have yet to receive any treatment. Receives: Diagnostic Test: Salivary Gamma-synuclein; Diagnostic Test: Incisional biopsy; Diagnostic Test: Conventional visual and tactile examination | |
| 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. Receives: Diagnostic Test: Salivary Gamma-synuclein; Diagnostic Test: Incisional biopsy; Diagnostic Test: Conventional visual and tactile examination | |
| 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 Receives: Diagnostic Test: Salivary Gamma-synuclein; Diagnostic Test: Conventional visual and tactile examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma-synuclein level sensitivity and specificity
Measured using ELISA reader
Measured: At same time as biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start10 Mar 2021 (estimated)
- Primary completion10 Dec 2021 (estimated)
- Study completion10 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma mohamed saad-eldin mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732741
- Sponsor's protocol ID
- SS2021
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions
- ClinicalTrials.gov ID
- NCT04732741
- Acronym / sponsor ID
- SS2021
- Conditions
- Oral Cancer, Oral Lichen Planus, Oral Leukoplakia, Premalignant Lesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (estimated)
- Primary completion
- 10 Dec 2021 (estimated)
- Study completion
- 10 Dec 2021 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Cancer | – | Diagnostic Test: Salivary Gamma-synuclein, Diagnostic Test: Incisional biopsy, Diagnostic Test: Conventional visual and tactile examinationpatients diagnosed clinically and histopathologically with oral cancer who have yet to receive any treatment. |
| Premalignant lesions | – | Diagnostic Test: Salivary Gamma-synuclein, Diagnostic Test: Incisional biopsy, Diagnostic Test: Conventional visual and tactile examinationpatients 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. |
| Control Group | – | Diagnostic Test: Salivary Gamma-synuclein, Diagnostic Test: Conventional visual and tactile examinationhealthy individuals who will be examined clinically through conventional visual and tactile examination to ensure no oral lesions are present and through thorough medical history |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary Gamma-synucleinGamma-synuclein salivary levels measured using ELISA assay | Diagnostic test | Control Group, Oral Cancer, Premalignant lesions |
| Incisional biopsyA) 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 | Oral Cancer, Premalignant lesions |
| Conventional visual and tactile examinationConventional visual and tactile examination using light and mirror | Diagnostic test | Control Group, Oral Cancer, Premalignant lesions |
Primary outcome
Gamma-synuclein level sensitivity and specificity
Time frame: At same time as biopsy
Measured using ELISA reader
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer and Oral Lichen Planus, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fat'heya Zahran (01060775113, fatheya.zahran@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gamma-synuclein level sensitivity and specificity (time frame: At same time as biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.