We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    MPR-1

Molecular Mechanisms of the Development of Precancerous and Cancerous Lesions of the Oral Cavity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03026361
First Posted: January 20, 2017
Last Update Posted: January 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Rijeka
Information provided by (Responsible Party):
Marinka Mravak Stipetic, University of Zagreb
  Purpose

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.


Condition Intervention
Oral Lichen Planus Oral Squamous Cell Carcinoma Genetic: global proteomic profiling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Mechanisms of Precancerous and Cancerous Lesions of the Oral Cavity

Resource links provided by NLM:


Further study details as provided by Marinka Mravak Stipetic, University of Zagreb:

Primary Outcome Measures:
  • Global proteomic profiling of oral lichen planus and oral squamous cell carcinoma [ Time Frame: 2012-2014 ]

Secondary Outcome Measures:
  • evaluation of the Insulin-like growth factor receptor 2 (IGF2R) and IGF2 role in oral lichen planus [ Time Frame: 2011-2014 ]

Enrollment: 71
Study Start Date: January 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Genetic: global proteomic profiling
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.
Other Names:
  • immunohistochemistry
  • Western blot
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.

Genetic: global proteomic profiling
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.
Other Names:
  • immunohistochemistry
  • Western blot
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.

Genetic: global proteomic profiling
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.
Other Names:
  • immunohistochemistry
  • Western blot

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • histopathologically confirmed oral lichen planus and oral squamous cell carcinoma
  • healthy volunteers referred for alveolotomy

Exclusion Criteria:

  • non-consent patients
  • previously treated OSCC
  • patients under immunosuppressive therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026361


Locations
Croatia
School of Dental Medicine, University of Zagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
University of Zagreb
University of Rijeka
Investigators
Principal Investigator: Marinka Mravak-Stipetic, Professor School of Dental Medicine
  More Information

Publications:
Responsible Party: Marinka Mravak Stipetic, Professor, University of Zagreb
ClinicalTrials.gov Identifier: NCT03026361     History of Changes
Other Study ID Numbers: 06509824642532
First Submitted: January 18, 2017
First Posted: January 20, 2017
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Lichen Planus
Lichen Planus, Oral
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases