Clinical Trial: Comparison of Morphometric Assessment Using Methyl Green Pyronin and AgNOR Staining of Oral Squamous Cell Carcinoma

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational [Patient Registry]

Official Title: Comparison of Morphometric Assessment Using Methyl Green Pyronin and AgNOR Staining of Oral Squamous Cell Carcinoma

Brief Summary:

Oral cancer represents the sixth most common cancer worldwide whilst in Pakistan it ranks the second most common cancer in either gender. Histologically, over 90% of oral cancer lesions are squamous cell carcinomas which are diagnosed on the basis of histopathological analysis. However, proliferation kinetics and nucleolar status are not clearly delineated by routine H&E examination; thus making use of various proliferation markers imperative for the purpose.

Nuclear organizer regions (AgNORs) are associated with proliferative activity and represents as a diagnostic aid in oral malignancies. Similarly, methyl green pyronin (MGP) stain has also been valuable as a complement in routine histopathological studies of several neoplastic entities.

Morphometric techniques offer an opportunity to quantify nuclear changes associated with malignancy and may provide an objective basis for grading the tumors. The present study is planned to analyze the morphometric parameters of the MGP stain in oral squamous cell carcinoma, and in their various histological grades, and to assess if the MGP staining parameters could give information on the aggressiveness of the malignant lesions of oral cavity.

Sections from thirty cases of squamous cell carcinoma along with thirty cases of normal oral mucosa will be evaluated for methyl green pyronin (MGP) and AgNOR staining. Morphometric analysis of various MGP staining and AgNOR parameters would be performed using micrometer. Statistical analysis of the results will be carried out using SPSS. Quantitative variables will be expressed as mean ± Standard Deviation. Frequencies and percentages will be given for qualitative variables.

It is hypothesized that oral squamous cell carcinoma will exhib

Detailed Summary:

Oral cancer, a major global health problem holds the sixth position worldwide with a marked variation in its geographic distribution. It is ranked as the third most frequent cancer in the developing world after stomach and cervical cancers. Amongst oral cancers, oral squamous cell carcinoma accounts for over 90% of the cases.

Out of the developing counties, Indo-Pak subcontinent amounts to one third of the global oral cancer burden. Carcinoma of the oral cavity in Pakistan, one of the high-risk countries is the second most frequent cancer in either gender. With differential distribution among sub-populations, it represents 8.8% of all reported cancer cases. The most predominant risk factors include tobacco smoking, betel chewing and alcohol.

Screening and specific diagnostic tools are two innovative approaches for early detection of oral cancer. Conventional oral examination and clinical evaluation remains the foundation of screening approaches whereas surgical biopsy followed by histological analysis is attributed to be the gold standard for diagnosing malignant oral lesions. Furthermore, some adjunctive techniques may contribute to the diagnosis of oral cancer. Of these vital staining, DNA analysis, chemiluminescence, tissue fluorescence, light-based detection systems and biomarkers are now on the forefront.

Biomarkers have been valuable in revealing additional information about tumor pathology, including the inactivation of tumor suppressor genes, angiogenesis, apoptosis and cell proliferation. Aberrations in proliferation kinetics are the most imperative factor during tumor progression. Three main categories of cell proliferation markers include growth fraction markers like Ki67, cycle-specific markers like PCNA(Proliferating Cellular Nuclear Antigen), and cell cycle ti
Sponsor: Academy of Interdisciplinary Dental Education and Research

Current Primary Outcome: Mean values of diameter, area and number of nuclei and nucleoli. [ Time Frame: Within one week of staining of slides ]

Morphometric parameters including diameter,area and number of nuclei and nucleoli will be determined using AgNOR and Methyl Green Pyronin staining methods.


Original Primary Outcome: Same as current

Current Secondary Outcome: Association of grading of OSCC in relation to morphometric parameters [ Time Frame: Within two weeks of staining of slides ]

Chi-square test or Fisher exact test will be applied to see any statistical association of grading of OSCC in relation to morphometric parameters.


Original Secondary Outcome: Same as current

Information By: Academy of Interdisciplinary Dental Education and Research

Dates:
Date Received: November 7, 2013
Date Started: June 2013
Date Completion: December 2013
Last Updated: November 13, 2013
Last Verified: November 2013