Oral Squamous Cell CarcinomaNCT05821179
Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma
An observational study of Oral Squamous Cell Carcinoma, run by Fayoum University at 1 site in Egypt.
Trial summary
This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Squamous Cell Carcinoma
- Type of treatment
- Pill or oral medicine
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 25 Feb 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - patients recruited from the outpatient clinic of departments of oral diagnosis and medicine and periodontology Fayoum, Beni-Suef and Ahram-Candian universities
Who may be able to join
- group I : oral squamous cell carcinoma lesions (OSCC)
- group II: oral lichen planus lesions (OLP)
- group III: systemically healthy volunteers
Who cannot join
- oral lesions other than OSCC / OLP in group I and II
- any oral lesion in group III
- pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included.
Read the detailed description
This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included, subdivided into 3 groups: Group I: 12 patients diagnosed with OSCC. Group II: 12 patients diagnosed with OLP. Group III: 12 systemically free individuals with no oral mucosal lesions. statistical analysis and ROC analysis were performed
- Conditions
- Oral Squamous Cell Carcinoma
- Keywords
- Oral squamous cell carcinoma, oral potentially malignant disorders, saliva, LINC00657, miR-106a.
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I | 12 patients diagnosed with OSCC. | |
| Group II | 12 patients diagnosed with OLP. | |
| Group III | 12 systemically free individuals with no oral mucosal lesions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LINC00657 level in salivary samples from all participants measured using PCR
quantitative real-time PCR is used to detect LINC00657 levels in saliva samples from patients with OSCC and OPMD compared to healthy subjects
Measured: level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation after diagnosis confirmation
Secondary outcomes (1)
miR-106a level in salivary samples from the included subjects evaluated by PCR
quantitative real-time PCR is used to detect miR106a levels in saliva samples from patients with OSCC and OPMD compared to healthy subjects
Measured: level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayroz Tarrad, Fayoum University
- Investigators
- Nayroz Tarrad, as. professor, Principal investigator, faculty of dentistry, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821179
- Sponsor's protocol ID
- M1
- Status last verified
- Apr 2023
- First submitted
- 26 Mar 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tarrad NAF, Hassan S, Shaker OG, AbdelKawy M. "Salivary LINC00657 and miRNA-106a as diagnostic biomarkers for oral squamous cell carcinoma, an observational diagnostic study". BMC Oral Health. 2023 Dec 12;23(1):994. doi: 10.1186/s12903-023-03726-0.
PubMed 38087258
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05821179
- Acronym / sponsor ID
- M1
- Conditions
- Oral Squamous Cell Carcinoma
- Keywords
- Oral squamous cell carcinoma, oral potentially malignant disorders, saliva, LINC00657, miR-106a.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 20 Apr 2023 (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.
This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included.
Detailed description
This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included, subdivided into 3 groups: Group I: 12 patients diagnosed with OSCC. Group II: 12 patients diagnosed with OLP. Group III: 12 systemically free individuals with no oral mucosal lesions. statistical analysis and ROC analysis were performed
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –12 patients diagnosed with OSCC. |
| Group II | – | –12 patients diagnosed with OLP. |
| Group III | – | –12 systemically free individuals with no oral mucosal lesions. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - patients recruited from the outpatient clinic of departments of oral diagnosis and medicine and periodontology Fayoum, Beni-Suef and Ahram-Candian universities
Key inclusion criteria (3 listed)
- group I : oral squamous cell carcinoma lesions (OSCC)
- group II: oral lichen planus lesions (OLP)
- group III: systemically healthy volunteers
Key exclusion criteria (3 listed)
- oral lesions other than OSCC / OLP in group I and II
- any oral lesion in group III
- pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LINC00657 level in salivary samples from all participants measured using PCR
Time frame: level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation after diagnosis confirmation
quantitative real-time PCR is used to detect LINC00657 levels in saliva samples from patients with OSCC and OPMD compared to healthy subjects
1 secondary outcome
miR-106a level in salivary samples from the included subjects evaluated by PCR
Time frame: level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Derived from this study: PubMed 38087258Tarrad NAF, Hassan S, Shaker OG, AbdelKawy M. "Salivary LINC00657 and miRNA-106a as diagnostic biomarkers for oral squamous cell carcinoma, an observational diagnostic study". BMC Oral Health. 2023 Dec 12;23(1):994. doi: 10.1186/s12903-023-03726-0.
- Individual participant dataSharing planned: No
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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.
Nayroz Tarrad, as. professor principal investigator
faculty of dentistry, Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma, run by Fayoum University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LINC00657 level in salivary samples from all participants measured using PCR (time frame: level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation after diagnosis confirmation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05821179, which also lists 1 linked publication.
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 20 Apr 2023.