Comparison of Morphometric Assessment Using Methyl Green Pyronin and AgNOR Staining of Oral Squamous Cell Carcinoma (OSCC)
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|ClinicalTrials.gov Identifier: NCT01987934|
Recruitment Status : Unknown
Verified November 2013 by Ali Raza, Academy of Interdisciplinary Dental Education and Research.
Recruitment status was: Enrolling by invitation
First Posted : November 20, 2013
Last Update Posted : November 20, 2013
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 exhibit significantly higher MGP staining and AgNOR staining parameters than normal mucosa of the oral cavity.
|Condition or disease|
|Oral Squamous Cell Carcinoma Oral Epithelial Dysplasia|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||60 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||2 Weeks|
|Official Title:||Comparison of Morphometric Assessment Using Methyl Green Pyronin and AgNOR Staining of Oral Squamous Cell Carcinoma|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||December 2013|
Normal or Control group
Those subjects with normal oral epithelium will be included in this group.
Those subjects with oral squamous cell carcinoma will be included in this group.
- 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.
- 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.
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987934
|Post Graduate Medical Institute|
|Lahore, Punjab, Pakistan, 54000|
|Study Director:||Muhammad Eyyaz Khaleel, M.Phil||Post Graduate Medical Institute, Lahore, Pakistan|
|Principal Investigator:||Ali Raza, B.D.S||Post Graduate Medical Institute, Lahore, Pakistan|