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NCT Number: NCT03026361

Molecular Mechanisms of the Development 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.

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Key information

Conditions

Oral Lichen Planus Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oral Squamous Cell Carcinoma Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

global proteomic profiling

Genetic

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

Primary outcomes

  1. Global proteomic profiling of oral lichen planus and oral squamous cell carcinoma

    Time frame: 2012-2014

Secondary outcomes

  1. evaluation of the Insulin-like growth factor receptor 2 (IGF2R) and IGF2 role in oral lichen planus

    Time frame: 2011-2014

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Collaborators

  • University of Rijeka

Registry information

Official study title

Molecular Mechanisms of Precancerous and Cancerous Lesions of the Oral Cavity

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2017
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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