Oral Lichen PlanusNCT02834520
Expression of miRNa-138 and Cyclin D1 in Oral Mucosa of Patients With Oral Lichen Planus
An observational study of Oral Lichen Planus, run by Cairo University.
Trial summary
60 individuals were subdivided into 2 groups, 30 patients with oral lichen planus, 30 control individuals. Expression of miRNA-138 and cyclin D1 were evaluated in oral mucosa utilizing Quantitative real-time polymerase chain reaction and immunohistochemistry. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Mar 2016
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60 individuals were subdivided into 2 groups, 30 patients suffering from oral lichen planus and 30 individuals having age, gender and periodontal status matched with both patients groups acting as a control group.
Who may be able to join
- patients with oral lichen planus.
Who cannot join
- any systemic disease other than oral lichen planus.
- smokers.
- pregnant females.
- periodontal diseases.
About this study
Official title: Expression of miRNA-138 and Cyclin D1 in Oral Lichen Planus (A Study Utilizing Immunohistochemistry and Real-time Polymerase Chain Reaction)
60 individuals were subdivided into 2 groups, 30 patients with oral lichen planus, 30 control individuals. Expression of miRNA-138 and cyclin D1 were evaluated in oral mucosa utilizing Quantitative real-time polymerase chain reaction and immunohistochemistry.
Read the detailed description
60 individuals were subdivided into 3 groups, into 2 groups, 30 patients with oral lichen planus, 30 control individuals having age, gender and periodontal status matched with both patients groups acting as a control group. Relative gene expression of miRNA-138 was estimated using Quantitative real-time polymerase chain reaction technique in oral mucosa of both oral lichen planus patients and control subjects. Sub grouping of oral lichen planus patients were performed into reticular, atrophic and erosive groups (n=10 each). Cyclin D1 gene expression was estimated using Quantitative real-time polymerase chain reaction technique and Cyclin D1 protein level was estimated using immunohistochemistry.
- Conditions
- Oral Lichen Planus
- 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.
| Study group | Role | What they receive |
|---|---|---|
| oral lichen planus | 30 patients suffering from reticular, erosive and atrophic oral lichen planus | |
| control subjects | 30 individuals age, gender and periodontal status matched with oral lichen planus patients and not suffering from any oral mucosal lesions or periodontal disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
expression of miRNA-138
expression of miRNA-138 in oral mucosa of patients with oral lichen planus
Measured: 1 day
Secondary outcomes (2)
gene expression of cyclin D1
gene expression of cyclin D1 in oral mucosa of patients with oral lichen planus
Measured: 1 day
protein expression of cyclin D1
protein expression of cyclin D1 in oral mucosa of patients with oral lichen planus
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies 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
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ayman Ghallab, Cairo University
- Investigators
- Noha Ghallab, MD, Principal investigator, Associate Professor of periodontology and Oral Medicine faulty of oral an
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834520
- Sponsor's protocol ID
- MiRNA-138_cyclin D1_OLP
- Status last verified
- Jul 2016
- First submitted
- 13 Jul 2016
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jiang L, Liu X, Kolokythas A, Yu J, Wang A, Heidbreder CE, Shi F, Zhou X. Downregulation of the Rho GTPase signaling pathway is involved in the microRNA-138-mediated inhibition of cell migration and invasion in tongue squamous cell carcinoma. Int J Cancer. 2010 Aug 1;127(3):505-12. doi: 10.1002/ijc.25320.
PubMed 20232393Liu X, Jiang L, Wang A, Yu J, Shi F, Zhou X. MicroRNA-138 suppresses invasion and promotes apoptosis in head and neck squamous cell carcinoma cell lines. Cancer Lett. 2009 Dec 28;286(2):217-22. doi: 10.1016/j.canlet.2009.05.030. Epub 2009 Jun 21.
PubMed 19540661Jin Y, Chen D, Cabay RJ, Wang A, Crowe DL, Zhou X. Role of microRNA-138 as a potential tumor suppressor in head and neck squamous cell carcinoma. Int Rev Cell Mol Biol. 2013;303:357-85. doi: 10.1016/B978-0-12-407697-6.00009-X.
PubMed 23445815Liu X, Lv XB, Wang XP, Sang Y, Xu S, Hu K, Wu M, Liang Y, Liu P, Tang J, Lu WH, Feng QS, Chen LZ, Qian CN, Bei JX, Kang T, Zeng YX. MiR-138 suppressed nasopharyngeal carcinoma growth and tumorigenesis by targeting the CCND1 oncogene. Cell Cycle. 2012 Jul 1;11(13):2495-506. doi: 10.4161/cc.20898. Epub 2012 Jul 1.
PubMed 22739938Yao X, Yin C, Shen LJ, Xie SM. [Expressions of NF--kappaBp65, TRAF2, cyclinD1 and their association with cell apoptosis in oral lichen planus]. Nan Fang Yi Ke Da Xue Xue Bao. 2007 Nov;27(11):1657-60. Chinese.
PubMed 18024283Hirota M, Ito T, Okudela K, Kawabe R, Yazawa T, Hayashi H, Nakatani Y, Fujita K, Kitamura H. Cell proliferation activity and the expression of cell cycle regulatory proteins in oral lichen planus. J Oral Pathol Med. 2002 Apr;31(4):204-12. doi: 10.1034/j.1600-0714.2002.310403.x.
PubMed 12076323
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of miRNA-138 and Cyclin D1 in Oral Lichen Planus (A Study Utilizing Immunohistochemistry and Real-time Polymerase Chain Reaction)
- ClinicalTrials.gov ID
- NCT02834520
- Acronym / sponsor ID
- MiRNA-138_cyclin D1_OLP
- Conditions
- Oral Lichen Planus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Jul 2016 (estimated)
- 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.
60 individuals were subdivided into 2 groups, 30 patients with oral lichen planus, 30 control individuals. Expression of miRNA-138 and cyclin D1 were evaluated in oral mucosa utilizing Quantitative real-time polymerase chain reaction and immunohistochemistry.
Detailed description
60 individuals were subdivided into 3 groups, into 2 groups, 30 patients with oral lichen planus, 30 control individuals having age, gender and periodontal status matched with both patients groups acting as a control group. Relative gene expression of miRNA-138 was estimated using Quantitative real-time polymerase chain reaction technique in oral mucosa of both oral lichen planus patients and control subjects. Sub grouping of oral lichen planus patients were performed into reticular, atrophic and erosive groups (n=10 each). Cyclin D1 gene expression was estimated using Quantitative real-time polymerase chain reaction technique and Cyclin D1 protein level was estimated using immunohistochemistry.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral lichen planus | – | –30 patients suffering from reticular, erosive and atrophic oral lichen planus |
| control subjects | – | –30 individuals age, gender and periodontal status matched with oral lichen planus patients and not suffering from any oral mucosal lesions or periodontal disease. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 individuals were subdivided into 2 groups, 30 patients suffering from oral lichen planus and 30 individuals having age, gender and periodontal status matched with both patients groups acting as a control group.
Key inclusion criteria (1 listed)
- patients with oral lichen planus.
Key exclusion criteria (4 listed)
- any systemic disease other than oral lichen planus.
- smokers.
- pregnant females.
- periodontal diseases.
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
expression of miRNA-138
Time frame: 1 day
expression of miRNA-138 in oral mucosa of patients with oral lichen planus
2 secondary outcomes
gene expression of cyclin D1
Time frame: 1 day
protein expression of cyclin D1
Time frame: 1 day
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 15 Jul 2016.
- Results publication: PubMed 20232393Jiang L, Liu X, Kolokythas A, Yu J, Wang A, Heidbreder CE, Shi F, Zhou X. Downregulation of the Rho GTPase signaling pathway is involved in the microRNA-138-mediated inhibition of cell migration and invasion in tongue squamous cell carcinoma. Int J Cancer. 2010 Aug 1;127(3):505-12. doi: 10.1002/ijc.25320.
- Results publication: PubMed 19540661Liu X, Jiang L, Wang A, Yu J, Shi F, Zhou X. MicroRNA-138 suppresses invasion and promotes apoptosis in head and neck squamous cell carcinoma cell lines. Cancer Lett. 2009 Dec 28;286(2):217-22. doi: 10.1016/j.canlet.2009.05.030. Epub 2009 Jun 21.
- Results publication: PubMed 23445815Jin Y, Chen D, Cabay RJ, Wang A, Crowe DL, Zhou X. Role of microRNA-138 as a potential tumor suppressor in head and neck squamous cell carcinoma. Int Rev Cell Mol Biol. 2013;303:357-85. doi: 10.1016/B978-0-12-407697-6.00009-X.
- Results publication: PubMed 22739938Liu X, Lv XB, Wang XP, Sang Y, Xu S, Hu K, Wu M, Liang Y, Liu P, Tang J, Lu WH, Feng QS, Chen LZ, Qian CN, Bei JX, Kang T, Zeng YX. MiR-138 suppressed nasopharyngeal carcinoma growth and tumorigenesis by targeting the CCND1 oncogene. Cell Cycle. 2012 Jul 1;11(13):2495-506. doi: 10.4161/cc.20898. Epub 2012 Jul 1.
- Results publication: PubMed 18024283Yao X, Yin C, Shen LJ, Xie SM. [Expressions of NF--kappaBp65, TRAF2, cyclinD1 and their association with cell apoptosis in oral lichen planus]. Nan Fang Yi Ke Da Xue Xue Bao. 2007 Nov;27(11):1657-60. Chinese.
- Results publication: PubMed 12076323Hirota M, Ito T, Okudela K, Kawabe R, Yazawa T, Hayashi H, Nakatani Y, Fujita K, Kitamura H. Cell proliferation activity and the expression of cell cycle regulatory proteins in oral lichen planus. J Oral Pathol Med. 2002 Apr;31(4):204-12. doi: 10.1034/j.1600-0714.2002.310403.x.
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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.
Noha Ghallab, MD principal investigator
Associate Professor of periodontology and Oral Medicine faulty of oral an
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 4 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 15 Jul 2016. 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?
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?
expression of miRNA-138 (time frame: 1 day). 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 NCT02834520, which also lists 6 linked publications.
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 15 Jul 2016.