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

NCT01987934 | Unknown DMC

• 1 other identifier: AIDER-1301-AR
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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 exhibit significantly higher MGP staining and AgNOR staining parameters than normal mucosa of the oral cavity.

Conditions

Oral Squamous Cell Carcinoma; Oral Epithelial Dysplasia

Keywords

Squamous Cell Carcinoma of the Head and Neck; Methyl Green Pyronin Staining; AgNORs; Morphometry

Outcome Measures

Primary Outcomes (1)

• Mean values of diameter, area and number of nuclei and nucleoli.

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

  Within one week of staining of slides

Secondary Outcomes (1)

• Association of grading of OSCC in relation to morphometric parameters

  Within two weeks of staining of slides

Study Arms (2)

Normal or Control group

Those subjects with normal oral epithelium will be included in this group.

Study Group

Those subjects with oral squamous cell carcinoma will be included in this group.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population comprises of subjects reporting to dental departments of tertiary care hospitals of Lahore district in Pakistan.

You may qualify if:

• Specimens of normal epithelium from healthy adult individuals irrespective of age and without habits that predispose to oral cancer
• Cases of clinically and histologically confirmed primary oral squamous cell carcinoma based on WHO criteria

You may not qualify if:

• Subjects of oral squamous cell carcinoma with any treatment therapy other than surgical excision.
• Subjects having metastatic tumors and tumors other than in the oral cavity
• Subjects having recurrent tumors.
• Subjects of normal or control group with history of risk / predisposing factors for oral cancer.

Sponsors & Collaborators

• Academy of Interdisciplinary Dental Education and Research: lead
• Postgraduate Medical Institute, Lahore: collaborator

Study Sites (1)

Post Graduate Medical Institute

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Mohtasham N, Mahdavi-Shahri N, Salehinejad J, Ejtehadi H, Torabi-Parizi M, Ghazi N. Detection of nucleoproteins in squamous cell carcinoma, and dysplastic and normal mucosa in the oral cavity by methyl green-pyronin staining. J Oral Sci. 2010 Jun;52(2):239-43. doi: 10.2334/josnusd.52.239.

  PMID: 20587947 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Oral mucosal biopsy specimens of study participants will be collected.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Muhammad Eyyaz Khaleel, M.Phil

  Postgraduate Medical Institute, Lahore

  STUDY DIRECTOR

• Ali Raza, B.D.S

  Postgraduate Medical Institute, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ali Raza

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 20, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

PA (1)