Oral Premalignant LesionsNCT04913545
The Senstivity and Specificity of Using Salivary miRNAs in Detection of Malignant Transformation of Oral Lesions.
An observational study of Oral Premalignant Lesions, run by Cairo University at 1 site in Egypt.
Trial summary
Due to cancer is a leading cause of death world wide , we will coduct the study to evaluate the diagnostic accuracy of using salivary miRNAs (412,512) from the salivary extracellular vesicles (index test) in detection of the malignant transformation of the premalignant lesions using the qualitative real time… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Premalignant Lesions
- What is being tested?
- using salivary miRNA (412,512)
- Type of treatment
- Pill or oral medicine
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2019to 7 Aug 2020
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Group of normal control subjects: 18 Healthy subjects presenting no clinically detectable oral lesions matched for age, gender, and risk factors .Group of subjects with potentially malignant lesions: 18 patient with innocuous lesions. * Group of subjects with malignant lesions:18 patient with suspicious lesions
Who may be able to join
- Clinically evident lesions as morphologically altered tissue noted at conventional visual tactile examination
- Clinically evident suspicious lesions which are morphologically altered tissue noted at comprehensive visual ductile examination ( CVTE) with a definitive diagnosis of a potentially malignant disorders (PMD) or even a malignant disorder to be a distinct possibly.
- Healthy subjects presenting no clinically detectable oral lesions matched for age, gender, and risk factors will recruited as controls.
Who cannot join
- .<18 years of age.
- pregnant or breast feeding. .psychiatrically or mentally unstable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Senstivity and Specificity of Using Salivary Extracellular Vesicles as Non -Invasive Source of miRNAs (412,512) in Detection of Malignant Transformation of Potientially Malignant Oral Lesions.
Due to cancer is a leading cause of death world wide , we will coduct the study to evaluate the diagnostic accuracy of using salivary miRNAs (412,512) from the salivary extracellular vesicles (index test) in detection of the malignant transformation of the premalignant lesions using the qualitative real time polymerase chain reaction (qRT-PCR) analysis in comparison to taking biopsy .
Read the detailed description
our study is a case control study,we will coduct our study to evaluate specificity and sensitivity of using salivary extracellular vesicles miRNAs (412,512) in detection of malignant transformation in potientially malignant oral lesions by using qRT-PCR analysis ,participants will be selected and arranged in 3 groups the control group, potentially malignant group and malignant group ,the salivary samples from the participants will be collected and then microRNA extraction steps will be done through the laboratory steps ,that include extracellular vesicles isolation, PCR Analysis for miRNA-412 and miRNA-512 expression ,also the histopathologic diagnosis and examination of all specimens were confirmed by pathologist.
- Conditions
- Oral Premalignant Lesions
- Being tested
- using salivary miRNA (412,512)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using salivary miRNA (412,512)Diagnostic test
Also called biopsy sample for potientially maliganat and malignant group
quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.
| Study group | Role | What they receive |
|---|---|---|
| normal group | participants with out any systemic medical problemes or oral lesions. we will only take saliva sample. Receives: Diagnostic Test: using salivary miRNA (412,512) | |
| potientially malignant group | participants with suspicious oral lesions without any medical diseases. we will take saliva sample and take a biopsy sample . Receives: Diagnostic Test: using salivary miRNA (412,512) | |
| malignant group | participants with already diagnosed oral malignant lesions without receiving any treatment yett Receives: Diagnostic Test: using salivary miRNA (412,512) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the sensitivity and specificity of salivary miRNAs (412,512) to detect the malignant transformation of oral potentially malignant lesions
measuring the sensitivity and specificity of using the salivary miRNAs(412,512)to detect the malignant transformation in potentially malignant lesions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start5 Jun 2019
- Primary completion7 Jan 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Premalignant LesionsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neveen Nabil Ghareeb, Cairo University
- Investigators
- Ghareeb, Principal investigator, Assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913545
- Sponsor's protocol ID
- 19 September,2018 ,Version 2
- Status last verified
- Jun 2021
- First submitted
- 29 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Senstivity and Specificity of Using Salivary Extracellular Vesicles as Non -Invasive Source of miRNAs (412,512) in Detection of Malignant Transformation of Potientially Malignant Oral Lesions.
- ClinicalTrials.gov ID
- NCT04913545
- Acronym / sponsor ID
- 19 September,2018 ,Version 2
- Conditions
- Oral Premalignant Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 4 Jun 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.
Due to cancer is a leading cause of death world wide , we will coduct the study to evaluate the diagnostic accuracy of using salivary miRNAs (412,512) from the salivary extracellular vesicles (index test) in detection of the malignant transformation of the premalignant lesions using the qualitative real time polymerase chain reaction (qRT-PCR) analysis in comparison to taking biopsy .
Detailed description
our study is a case control study,we will coduct our study to evaluate specificity and sensitivity of using salivary extracellular vesicles miRNAs (412,512) in detection of malignant transformation in potientially malignant oral lesions by using qRT-PCR analysis ,participants will be selected and arranged in 3 groups the control group, potentially malignant group and malignant group ,the salivary samples from the participants will be collected and then microRNA extraction steps will be done through the laboratory steps ,that include extracellular vesicles isolation, PCR Analysis for miRNA-412 and miRNA-512 expression ,also the histopathologic diagnosis and examination of all specimens were confirmed by pathologist.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal group | – | Diagnostic Test: using salivary miRNA (412,512)participants with out any systemic medical problemes or oral lesions. we will only take saliva sample. |
| potientially malignant group | – | Diagnostic Test: using salivary miRNA (412,512)participants with suspicious oral lesions without any medical diseases. we will take saliva sample and take a biopsy sample . |
| malignant group | – | Diagnostic Test: using salivary miRNA (412,512)participants with already diagnosed oral malignant lesions without receiving any treatment yett |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Group of normal control subjects: 18 Healthy subjects presenting no clinically detectable oral lesions matched for age, gender, and risk factors .Group of subjects with potentially malignant lesions: 18 patient with innocuous lesions. * Group of subjects with malignant lesions:18 patient with suspicious lesions
Key inclusion criteria (3 listed)
- Clinically evident lesions as morphologically altered tissue noted at conventional visual tactile examination
- Clinically evident suspicious lesions which are morphologically altered tissue noted at comprehensive visual ductile examination ( CVTE) with a definitive diagnosis of a potentially malignant disorders (PMD) or even a malignant disorder to be a distinct possibly.
- Healthy subjects presenting no clinically detectable oral lesions matched for age, gender, and risk factors will recruited as controls.
Key exclusion criteria (2 listed)
- .<18 years of age.
- pregnant or breast feeding. .psychiatrically or mentally unstable.
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 |
|---|---|---|
| using salivary miRNA (412,512)Also: biopsy sample for potientially maliganat and malignant groupquantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions. | Diagnostic test | malignant group, normal group, potientially malignant group |
Primary outcome
the sensitivity and specificity of salivary miRNAs (412,512) to detect the malignant transformation of oral potentially malignant lesions
Time frame: 2 years
measuring the sensitivity and specificity of using the salivary miRNAs(412,512)to detect the malignant transformation in potentially malignant lesions
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 9 Jun 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.
Ghareeb principal investigator
Assistant lecturer
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 Premalignant Lesions, run by Cairo 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 2 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 9 Jun 2021. 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?
the sensitivity and specificity of salivary miRNAs (412,512) to detect the malignant transformation of oral potentially malignant lesions (time frame: 2 years). 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 9 Jun 2021.