Lichen Planus, OralNCT03687437
Lichen Planus and Mean Platelet Volum
An observational study of Lichen Planus, Oral, run by Cairo University at 2 sites in Egypt.
Trial summary
70 patients with suspicious oral lichen planus; atrophic and bullous erosive forms will be included. The blood samples will be drawn between 08:00 and 09:00 AM, after a fasting period of 12 hours, and analysis were performed within 2 hours of the sampling. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lichen Planus, Oral
- What is being tested?
- Blood sample
- How many people
- 70 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Jun 2018to 1 Mar 2019
- 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 18 to 60 years
- All sexes
- Adult
Study population: Patients suspected to have oral lichen planus
Who may be able to join
- Inclusion criteria is suspected oral lichen planus, age 18-60
Who cannot join
- Foreseeable missing opportunity of follow-up examination, Pregnancy, heart-, pulmonary, liver- and kidney disease, chronic pain syndrome nursing, drug addiction, recent operations, and diseases like heart, metabolism, CNS, infectious, circulation, systemic, malignant and immune system affecting diseases as well as blood coagulation disorders and allergic reactions to pharmaceuticals and antibiotics
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Oral Medicine and Periodontology Department
Cairo
Faculty of Dentistry, Cairo University
Giza
About this study
Official title: Diagnostic Accuracy of the Mean Platelet Volume in Oral Lichen Planus
70 patients with suspicious oral lichen planus; atrophic and bullous erosive forms will be included. The blood samples will be drawn between 08:00 and 09:00 AM, after a fasting period of 12 hours, and analysis were performed within 2 hours of the sampling. The MPV and other hematologic parameters will be measured in a blood sample. A surgical biopsy will be performed for histopathological assessment.
Read the detailed description
70 patients with suspicious oral lichen planus; atrophic and bullous erosive forms will be included for conventional clinical examination under incandescent projected light. Using biopsy as a gold standard, all patients will be biopsied.
Blood Samples For all participants, the blood samples will be drawn between 08:00 and 09:00 AM, after a fasting period of 12 hours, and analysis were performed within 2 hours of the sampling. The MPV and other hematologic parameters will be measured in a blood sample that will be collected in tubes containing EDTA. Complete blood cell analysis will be performed in hematology laboratory, New Kasr Al-Aini Teaching Hospital, Faculty of Medicine, Cairo University. For reliable MPV measurement, the investigator will standardize the time delay between sampling and analysis to <2 hours for all patients.
Biopsy preparation A surgical biopsy will be performed for histopathological assessment. All clinically identified lesions underwent biopsies where specimens will be placed in 10% buffered formalin for fixation. Paraffin embedded material will be cut into 4 μm thick sections and will be stained with haematoxylin + eosin then submitted for histopathological evaluation by a senior oral pathologist blinded to the clinical findings.
Statistical analysis
The collected data will be entered through the SPSS version 18.0 software. Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV) and Accuracy were calculated for MPV. The results will be compared with histopathological results using Chi-Square test with p value set as < 0.05.
- Conditions
- Lichen Planus, Oral
- Being tested
- Blood sample
- Keywords
- Oral lichen planus, mean platelet volume
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Also called Biopsy
Complete blood count
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete blood count
blood sample between 08:00 and 09:00 AM and analysis to <2 hours for all patients
Measured: Once at the time of the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start30 Jun 2018
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
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 Lichen Planus, OralStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Zakaria Ibrahium Mohammed, Cairo University
- Investigators
- Dalia El Rouby, PH, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687437
- Sponsor's protocol ID
- Mai Zakaria
- Status last verified
- Jul 2019
- First submitted
- 24 Sep 2018
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta S, Ghosh S, Gupta S. Interventions for the management of oral lichen planus: a review of the conventional and novel therapies. Oral Dis. 2017 Nov;23(8):1029-1042. doi: 10.1111/odi.12634. Epub 2017 Mar 3.
PubMed 28055124
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the Mean Platelet Volume in Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT03687437
- Acronym / sponsor ID
- Mai Zakaria
- Conditions
- Lichen Planus, Oral
- Keywords
- Oral lichen planus, mean platelet volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 27 Sep 2018 (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.
70 patients with suspicious oral lichen planus; atrophic and bullous erosive forms will be included. The blood samples will be drawn between 08:00 and 09:00 AM, after a fasting period of 12 hours, and analysis were performed within 2 hours of the sampling. The MPV and other hematologic parameters will be measured in a blood sample. A surgical biopsy will be performed for histopathological assessment.
Detailed description
70 patients with suspicious oral lichen planus; atrophic and bullous erosive forms will be included for conventional clinical examination under incandescent projected light. Using biopsy as a gold standard, all patients will be biopsied.
Blood Samples For all participants, the blood samples will be drawn between 08:00 and 09:00 AM, after a fasting period of 12 hours, and analysis were performed within 2 hours of the sampling. The MPV and other hematologic parameters will be measured in a blood sample that will be collected in tubes containing EDTA. Complete blood cell analysis will be performed in hematology laboratory, New Kasr Al-Aini Teaching Hospital, Faculty of Medicine, Cairo University. For reliable MPV measurement, the investigator will standardize the time delay between sampling and analysis to <2 hours for all patients.
Biopsy preparation A surgical biopsy will be performed for histopathological assessment. All clinically identified lesions underwent biopsies where specimens will be placed in 10% buffered formalin for fixation. Paraffin embedded material will be cut into 4 μm thick sections and will be stained with haematoxylin + eosin then submitted for histopathological evaluation by a senior oral pathologist blinded to the clinical findings.
Statistical analysis
The collected data will be entered through the SPSS version 18.0 software. Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV) and Accuracy were calculated for MPV. The results will be compared with histopathological results using Chi-Square test with p value set as < 0.05.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients suspected to have oral lichen planus
Key inclusion criteria (1 listed)
- Inclusion criteria is suspected oral lichen planus, age 18-60
Key exclusion criteria (1 listed)
- Foreseeable missing opportunity of follow-up examination, Pregnancy, heart-, pulmonary, liver- and kidney disease, chronic pain syndrome nursing, drug addiction, recent operations, and diseases like heart, metabolism, CNS, infectious, circulation, systemic, malignant and immune system affecting diseases as well as blood coagulation disorders and allergic reactions to pharmaceuticals and antibiotics
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 |
|---|---|---|
| Blood sampleAlso: BiopsyComplete blood count | Diagnostic test | – |
Primary outcome
Complete blood count
Time frame: Once at the time of the first visit
blood sample between 08:00 and 09:00 AM and analysis to <2 hours for all patients
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 24 Jul 2019.
- Background: PubMed 28055124Gupta S, Ghosh S, Gupta S. Interventions for the management of oral lichen planus: a review of the conventional and novel therapies. Oral Dis. 2017 Nov;23(8):1029-1042. doi: 10.1111/odi.12634. Epub 2017 Mar 3.
- Individual participant dataSharing planned: No
Related trials for Lichen Planus, Oral
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
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Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
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Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
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Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
RecruitingPhase 2/3
A Phase 2/3 Study of Brepocitinib in Adults With Lichen Planopilaris
Lichen Planopilaris
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.
Dalia El Rouby, PH study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lichen Planus, Oral, run by Cairo University at 2 sites 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 1 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: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Complete blood count (time frame: Once at the time of the first visit). 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 NCT03687437, 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 24 Jul 2019.