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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
Sponsor:
Collaborator:
Post Graduate Medical Institute, Lahore, Pakistan
Information provided by (Responsible Party):
Ali Raza, Academy of Interdisciplinary Dental Education and Research

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.


Condition or disease
Oral Squamous Cell Carcinoma Oral Epithelial Dysplasia

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
Oral mucosal biopsy specimens of study participants will be collected.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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): NCT01987934


Locations
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Pakistan
Post Graduate Medical Institute
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Academy of Interdisciplinary Dental Education and Research
Post Graduate Medical Institute, Lahore, Pakistan
Investigators
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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

Additional Information:

Publications:
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Responsible Party: Ali Raza, Dr. Ali Raza, Academy of Interdisciplinary Dental Education and Research
ClinicalTrials.gov Identifier: NCT01987934    
Other Study ID Numbers: AIDER-1301-AR
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013
Keywords provided by Ali Raza, Academy of Interdisciplinary Dental Education and Research:
Squamous Cell Carcinoma of the Head and Neck
Methyl Green Pyronin Staining
AgNORs
Morphometry
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell