Oral Lichen PlanusNCT03026361
Molecular Mechanisms of the Development of Precancerous and Cancerous Lesions of the Oral Cavity
An observational study of Oral Lichen Planus and Oral Squamous Cell Carcinoma, run by University of Zagreb at 1 site in Croatia.
Trial summary
The aim of this study was to examine molecular alterations on the protein level in lesions of oral lichen planus (OLP), oral squamous cell carcinoma (OSCC) and healthy mucosa. Global protein profiling methods based on liquid chromatography coupled to mass spectrometry were used, with a special emphasis on evaluation… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus, Oral Squamous Cell Carcinoma
- What is being tested?
- global proteomic profiling
- Type of treatment
- Pill or oral medicine
- How many people
- 71 participants
- Where
- 1 siteCroatia
- Study dates
- Jan 2010to Dec 2014
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A study consisted of 71 consented patients, among which 27 with histologically confirmed diagnosis of oral lichen planus, 23 with oral squamous cell carcinoma and 21 sample of healthy oral mucosa (18 archive samples). Study included 36 male and 35 female patients.
Who may be able to join
- histopathologically confirmed oral lichen planus and oral squamous cell carcinoma
- healthy volunteers referred for alveolotomy
Who cannot join
- non-consent patients
- previously treated OSCC
- patients under immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Mechanisms of Precancerous and Cancerous Lesions of the Oral Cavity
The aim of this study was to examine molecular alterations on the protein level in lesions of oral lichen planus (OLP), oral squamous cell carcinoma (OSCC) and healthy mucosa. Global protein profiling methods based on liquid chromatography coupled to mass spectrometry were used, with a special emphasis on evaluation of deregulated extracellular matrix molecules expression, as well as on analyses of insulin-like growtg factor 2 (IG2F) and insulin-like growth factor 2 receptor (IGFR2) expression in healthy mucosa, OLP and OSCC tissues by comparative semiquantitative immunohistochemistry.
Mass spectrometry based proteomics profiling of healthy mucosa, OLP and OSCC tissues (and accompanied histologically unaltered tissues, respectively) identified 55 extracellular matrix proteins. Twenty among identified proteins were common to all groups of samples. Statistically significant difference between final IGF2 and IGF2R IRS scores in favour to IGF2R may further corroborate the IG2FR antitumor role in OLP and OSCC where it acts as a negative regulator of IGF2 activity.
Read the detailed description
Although OLP is categorised as a precancerous condition associated with a significantly increased risk of oral cancer, molecular pathophysiology of OLP and its potential for malignant transformation in OSCC are poorly understood and remain controversial. Development of new analytical methods enhances research in the field of malignant disorders. Identification of novel biomarkers help in the diagnostic process, pre-symptomatic interventions or prediction of treatment response. Proteomics based on mass spectrometry enables analysis of novel, putative biomarkers. In this study, proteomics was used to analyse in more details extracellular matrix (ECM) proteins and proteins related to ECM signalization which have a well-established role in malignant transformation and invasion of tumor cells.
IGF2 and IGF2R are known biomarkers in cellular metabolism,but their role in oral precancerous lesions, namely oral lichen planus (OLP) as well as in oral squamous cell carcinoma (OSCC) has not been explored so far. The second aim of our study was to analyse IG2F and IGFR2 expression in oral lichen planus and oral squamous cell carcinoma tissues by comparative semiquantitative immunohistochemistry
- Conditions
- Oral Lichen Planus, Oral Squamous Cell Carcinoma
- Being tested
- global proteomic profiling
- Medical subject headings
- Lichen Planus, Oral, 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.
global proteomic profilingGenetic
Also called immunohistochemistry, Western blot
Global proteomic profiling was performed on OLP and OSCC samples and healthy mucosa. Obtained data was analysed in Uniprot database (http://uniprot.org) with the emphasis on extracellular matrix proteins. In total, 55 extracellular matrix proteins were found to be expressed in analysed samples with very high confidence.
| Study group | Role | What they receive |
|---|---|---|
| oral lichen planus (OLP) | Histopathologically confirmed samples of OLP underwent immunohistochemical analysis of IGF2 and IGF2R expression.
Fresh-frozen samples of clinically OLP changed and adjacent healthy mucosa underwent global proteomic profiling and two proteins were subsequently validated with Western blot. Receives: Genetic: global proteomic profiling | |
| oral squamous cell carcinoma (OSCC) | Histopathologically confirmed samples of OSCC underwent immunohistochemical analysis of IGF2 and IGF2R expression.
Fresh-frozen samples of clinically OSCC changed and adjacent healthy mucosa underwent global proteomic profiling and two proteins were subsequently validated with Western blot. Receives: Genetic: global proteomic profiling | |
| healthy mucosa | Archival samples of healthy oral mucosa underwent immunohistochemical analysis of IGF2 and IGF2R expression.
Fresh-frozen samples of healthy mucosa taken during alveolotomy underwent global proteomic profiling and two proteins were subsequently validated with Western blot. Receives: Genetic: global proteomic profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global proteomic profiling of oral lichen planus and oral squamous cell carcinoma
Measured: 2012-2014
Secondary outcomes (1)
evaluation of the Insulin-like growth factor receptor 2 (IGF2R) and IGF2 role in oral lichen planus
Measured: 2011-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startJan 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rijeka
- Responsible party
- Principal investigator, Marinka Mravak Stipetic, University of Zagreb
- Investigators
- Marinka Mravak-Stipetic, Professor, Principal investigator, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026361
- Sponsor's protocol ID
- 06509824642532
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2017
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Schiller HB, Szekeres A, Binder BR, Stockinger H, Leksa V. Mannose 6-phosphate/insulin-like growth factor 2 receptor limits cell invasion by controlling alphaVbeta3 integrin expression and proteolytic processing of urokinase-type plasminogen activator receptor. Mol Biol Cell. 2009 Feb;20(3):745-56. doi: 10.1091/mbc.e08-06-0569. Epub 2008 Nov 26.
PubMed 19037107Zavras AI, Pitiphat W, Wu T, Cartsos V, Lam A, Douglass CW, Diehl SR. Insulin-like growth factor II receptor gene-167 genotype increases the risk of oral squamous cell carcinoma in humans. Cancer Res. 2003 Jan 15;63(2):296-7.
PubMed 12543777Pawar H, Kashyap MK, Sahasrabuddhe NA, Renuse S, Harsha HC, Kumar P, Sharma J, Kandasamy K, Marimuthu A, Nair B, Rajagopalan S, Maharudraiah J, Premalatha CS, Kumar KV, Vijayakumar M, Chaerkady R, Prasad TS, Kumar RV, Kumar RV, Pandey A. Quantitative tissue proteomics of esophageal squamous cell carcinoma for novel biomarker discovery. Cancer Biol Ther. 2011 Sep 15;12(6):510-22. doi: 10.4161/cbt.12.6.16833. Epub 2011 Sep 15.
PubMed 21743296
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms of Precancerous and Cancerous Lesions of the Oral Cavity
- ClinicalTrials.gov ID
- NCT03026361
- Acronym / sponsor ID
- 06509824642532
- Conditions
- Oral Lichen Planus, Oral Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Collaborators
- University of Rijeka
- Study start
- Jan 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Jan 2017 (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.
The aim of this study was to examine molecular alterations on the protein level in lesions of oral lichen planus (OLP), oral squamous cell carcinoma (OSCC) and healthy mucosa. Global protein profiling methods based on liquid chromatography coupled to mass spectrometry were used, with a special emphasis on evaluation of deregulated extracellular matrix molecules expression, as well as on analyses of insulin-like growtg factor 2 (IG2F) and insulin-like growth factor 2 receptor (IGFR2) expression in healthy mucosa, OLP and OSCC tissues by comparative semiquantitative immunohistochemistry.
Mass spectrometry based proteomics profiling of healthy mucosa, OLP and OSCC tissues (and accompanied histologically unaltered tissues, respectively) identified 55 extracellular matrix proteins. Twenty among identified proteins were common to all groups of samples. Statistically significant difference between final IGF2 and IGF2R IRS scores in favour to IGF2R may further corroborate the IG2FR antitumor role in OLP and OSCC where it acts as a negative regulator of IGF2 activity.
Detailed description
Although OLP is categorised as a precancerous condition associated with a significantly increased risk of oral cancer, molecular pathophysiology of OLP and its potential for malignant transformation in OSCC are poorly understood and remain controversial. Development of new analytical methods enhances research in the field of malignant disorders. Identification of novel biomarkers help in the diagnostic process, pre-symptomatic interventions or prediction of treatment response. Proteomics based on mass spectrometry enables analysis of novel, putative biomarkers. In this study, proteomics was used to analyse in more details extracellular matrix (ECM) proteins and proteins related to ECM signalization which have a well-established role in malignant transformation and invasion of tumor cells.
IGF2 and IGF2R are known biomarkers in cellular metabolism,but their role in oral precancerous lesions, namely oral lichen planus (OLP) as well as in oral squamous cell carcinoma (OSCC) has not been explored so far. The second aim of our study was to analyse IG2F and IGFR2 expression in oral lichen planus and oral squamous cell carcinoma tissues by comparative semiquantitative immunohistochemistry
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| oral lichen planus (OLP) | – | Genetic: global proteomic profilingHistopathologically confirmed samples of OLP underwent immunohistochemical analysis of IGF2 and IGF2R expression. Fresh-frozen samples of clinically OLP changed and adjacent healthy mucosa underwent global proteomic profiling and two proteins were subsequently validated with Western blot. |
| oral squamous cell carcinoma (OSCC) | – | Genetic: global proteomic profilingHistopathologically confirmed samples of OSCC underwent immunohistochemical analysis of IGF2 and IGF2R expression. Fresh-frozen samples of clinically OSCC changed and adjacent healthy mucosa underwent global proteomic profiling and two proteins were subsequently validated with Western blot. |
| healthy mucosa | – | Genetic: global proteomic profilingArchival samples of healthy oral mucosa underwent immunohistochemical analysis of IGF2 and IGF2R expression. Fresh-frozen samples of healthy mucosa taken during alveolotomy underwent global proteomic profiling and two proteins were subsequently validated with Western blot. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A study consisted of 71 consented patients, among which 27 with histologically confirmed diagnosis of oral lichen planus, 23 with oral squamous cell carcinoma and 21 sample of healthy oral mucosa (18 archive samples). Study included 36 male and 35 female patients.
Key inclusion criteria (2 listed)
- histopathologically confirmed oral lichen planus and oral squamous cell carcinoma
- healthy volunteers referred for alveolotomy
Key exclusion criteria (3 listed)
- non-consent patients
- previously treated OSCC
- patients under immunosuppressive therapy
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 |
|---|---|---|
| global proteomic profilingAlso: immunohistochemistry, Western blotGlobal proteomic profiling was performed on OLP and OSCC samples and healthy mucosa. Obtained data was analysed in Uniprot database (http://uniprot.org) with the emphasis on extracellular matrix proteins. In total, 55 extracellular matrix proteins were found to be expressed in analysed samples with very high confidence. | Genetic | healthy mucosa, oral lichen planus (OLP), oral squamous cell carcinoma (OSCC) |
Primary outcome
Global proteomic profiling of oral lichen planus and oral squamous cell carcinoma
Time frame: 2012-2014
1 secondary outcome
evaluation of the Insulin-like growth factor receptor 2 (IGF2R) and IGF2 role in oral lichen planus
Time frame: 2011-2014
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 Jan 2017.
- Results publication: PubMed 19037107Schiller HB, Szekeres A, Binder BR, Stockinger H, Leksa V. Mannose 6-phosphate/insulin-like growth factor 2 receptor limits cell invasion by controlling alphaVbeta3 integrin expression and proteolytic processing of urokinase-type plasminogen activator receptor. Mol Biol Cell. 2009 Feb;20(3):745-56. doi: 10.1091/mbc.e08-06-0569. Epub 2008 Nov 26.
- Results publication: PubMed 12543777Zavras AI, Pitiphat W, Wu T, Cartsos V, Lam A, Douglass CW, Diehl SR. Insulin-like growth factor II receptor gene-167 genotype increases the risk of oral squamous cell carcinoma in humans. Cancer Res. 2003 Jan 15;63(2):296-7.
- Results publication: PubMed 21743296Pawar H, Kashyap MK, Sahasrabuddhe NA, Renuse S, Harsha HC, Kumar P, Sharma J, Kandasamy K, Marimuthu A, Nair B, Rajagopalan S, Maharudraiah J, Premalatha CS, Kumar KV, Vijayakumar M, Chaerkady R, Prasad TS, Kumar RV, Kumar RV, Pandey A. Quantitative tissue proteomics of esophageal squamous cell carcinoma for novel biomarker discovery. Cancer Biol Ther. 2011 Sep 15;12(6):510-22. doi: 10.4161/cbt.12.6.16833. Epub 2011 Sep 15.
- 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.
Marinka Mravak-Stipetic, Professor principal investigator
University of Zagreb
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 Lichen Planus and Oral Squamous Cell Carcinoma, run by University of Zagreb at 1 site in Croatia.
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 2 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 Jan 2017. 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 Croatia. 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?
Global proteomic profiling of oral lichen planus and oral squamous cell carcinoma (time frame: 2012-2014). 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 NCT03026361, which also lists 3 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 20 Jan 2017.