Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Ovarian Neoplasms
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Retrospective

Participation Requirements

Age
Younger than 61 years
Gender
Only males

Description

In this study , we aim to : 1-Evaluate the immunohistochemical expression of p16 in both neoplastic and stromal components of benign and malignant OGCTs and scoring its immunoreactivity. 2-Correlate between P16 immunohistochemical expression with clinicopathological parameters (Age, Histopathologica...

In this study , we aim to : 1-Evaluate the immunohistochemical expression of p16 in both neoplastic and stromal components of benign and malignant OGCTs and scoring its immunoreactivity. 2-Correlate between P16 immunohistochemical expression with clinicopathological parameters (Age, Histopathological type, grading, and staging). Type of the study: Matched case-control study. Study subjects: Inclusion criteria: Different types of Ovarian germ cell tumors including : benign ( mature cystic teratoma ) and malignant ones ( dysgerminoma , immature teratoma and yolk sac tumor ) . Exclusion criteria: Any criteria that not fulfill the inclusion criteria such as resected ovarian tumors other than ovarian germ cell tumors e.g epithelial ovarian tumors, sex cord -stromal tumors or metastatic ovarian lesions. Sample Size Calculation: by Open Epi version 3. As regards review of literature: Risk of exposure measures % of P16 protein IHC expression in tissue. In normal ovarian tissue as Control group: measured approximately (50%). In malignant OGCT as case group: has decreased or absent expression (equals 10 % or less). And benign OGCT will be represented as equal comparison group. Materials and methods : Formalin fixed paraffin embedded blocks of eighty ovarian specimens will be included in this study. These specimens will be divided into 2 groups: Forty surgically resected ovarian germ cell tumors specimens: twenty malignant ones( dysgerminoma , immature teratoma and yolk sac tumor) as a case group and equal twenty benign ones (mature cystic teratoma ) as comparison group with mean age 17 years old. Forty normally apparent ovaries that surgically resected with specimens of total abdominal hysterectomy and salpingo-Oopherctomy for non-ovarian causes in perimenopausal women as a control group with mean age 40 years old. Adjustment of confounders (as Age) is not to be statistically significant. These specimens will be retrieved from the surgical pathology Lab of Assiut University hospital (AUH) from January 2010 to January 2021. The clinical data includes age, marital status, parity and laterality of lesions will be evaluated according to pathological referral records. Histopathological examination of sections stained with hematoxylin and eosin from cases of ovarian germ cell tumors by routine light microscopy to determine type, grade and pathological stage of the tumor. Immunohistochemical stain using anti-p16 antibody with immunoperoxidase staining as a visualization method. Antibody dilution, antigen retrieval methods and incubation time will all be conducted according to the manufacturer's instructions. 4- Scoring and evaluation of immunohistochemistry: Semi-quantitative approach using H-score will be used to evaluate the staining as previously mentioned. A final score ranges from 0-300 will be obtained by multiplying the staining intensity (0: negative, 1: weakly positive, 2: moderately positive and 3: strongly positive) and the percentage of positive cells. 5-Data management and analysis: Computer software: All statistical analysis will be performed using software package SPSS version 16. Statistical tests: The numerical data will be presented as mean and standard deviation, while categorical data will be presented as number and percentage. Chi-square test will be used to evaluate the association between P16 immunohistochemistry and pathological variables. Adjustment of confounders (as Age) is not to be statistically significant. P value less than 0.05 will be considered statistically significant. Multivariate Cox regression analysis will be performed.

Tracking Information

NCT #
NCT04283773
Collaborators
Not Provided
Investigators
Not Provided