Immunohistochemical Evaluation of Protein P16 Expression in Ovarian Germ Cell Tumors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- P16 Evaluation in Ovarian Germ Cell Tumors
研究概览
简要总结
Ovarian germ cell tumors (OGCTs) constitute 10% of ovarian tumors in Egypt and mainly affect young females. Teratomas are the most common type.Most of teratomas is benign. However, it is liable for malignant transformation. Others are malignant including dysgerminoma, immature teratoma, yolk sac tumor,.etc and accounts 1-1.5% of cancers in young females. The pathogenesis of OGCTs is not clearly understood.
P16 is a member of cyclin-dependent kinase (CDK) inhibitors. It arrests the cell cycle in G1 phase, so it is known as a tumor suppressor protein.P16 immunohistochemical(IHC) expression has been widely investigated in different cancers. Its IHC expression is either absent or overexpressed. Overexpression of p16 is documented in Human Papilloma Virus related endocervical neoplasms and High grade squamous intraepithelial lesions of the vulvovaginal region.Absence of p16 expression is detected in multiple cancers such as Lung cancer, colorectal cancer and lymphoma.
P16 IHC expression in OGCTs is poorly investigated. One study suggests that absent p16 is involved in proliferation of malignant OGCTs via molecular assessment.Another study suggested that decrease P16 is involved in malignant transformation of Mature cystic teratoma to squamous cell carcinoma.However, Previous studies are still limited and recommended further studies to confirm its results.
As the role of altered P16 protein in OGCTs is not widely investigated, we hypothesized that abnormal P16 expression may be involved in its pathogenesis and germ stem cell proliferation.This will give more information about molecular pathways of germ stem cell proliferation to give a hope for CDK inhibitors as novel target therapies in the management of OGCTs.
详细描述
In this study , we aim to :
1-Evaluate the immunohistochemical expression of p16 in neoplastic component of benign and malignant OGCTs and scoring its immunoreactivity.
2-Correlate between P16 immunohistochemical expression in MOGCTs with Ki 67 proliferating index and FIGO staging.
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Type of the study: Matched case-control study.
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Study subjects:
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Inclusion criteria: Different types of Ovarian germ cell tumors including : benign ( mature cystic teratoma ) and malignant ones ( dysgerminoma , immature teratoma and yolk sac tumor ) .
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Exclusion criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Months 至 1 Year(Child)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ovarian germ cell tumors :
- •20 benign ( mature cystic teratoma ).
- •22 malignant ones ( 5 dysgerminoma , 8 immature teratoma and 9 yolk sac tumor).
- •20 Normal ovaries .
排除标准
- •Epithelial ovarian tumors
- •sex cord -stromal ovarian tumors.
- •metastatic ovarian lesions.
结局指标
主要结局
P16 Evaluation in Ovarian Germ Cell Tumors
时间窗: Antibody exposure overnight, assessed up to 3 days for each run of sections assessed.
For P16 IHC staining, the percentage of P16 positive cells and the location of positive signals (nuclear or cytoplasmic) were visually estimated for neoplastic components of all lesions. German Semi-quantitative scoring system were used to evaluate P16 expression as every tumor will be given a score according to the intensity of the cytoplasmic and nucleic staining (no staining = 0, weak staining = 1, moderate staining = 2, strong staining = 3) And the extent of stained cells (0% = 0, 1-10% = 1, 11-50% =2, 51-80% = 3, 81-100% = 4). The final immunoreactive score will be determined by multiplying the intensity scores with the extent of positivity scores of stained cells, with the minimum score of 0 and a maximum score of 12 ( score 0, 1,2,3,4,6,8,9 and 12).
Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.
时间窗: Antibody exposure 2 hrs , assessed up to 1 day for each run of sections assessed.
For KI67 IHC staining for malignant cases, percentage of nuclear positivity stained cells were assessed, regardless intensity of staining in all sections examined (at least 1000 tumor cells were counted per section for estimation of KI index).Correlation analysis was used to test the association between Ki-67 and other variables (Spearman' Ranked correlation). A p-value \< 0.05 was considered significant.
次要结局
- Correlation Between P16 Cytoplasmic Score and FIGO Staging of MOGCTs.(After obtaining of results and collecting raw data , within 2 months.)
研究者
Omar A Ahmed
Demonstrator at Pathology department - faculty of medicine - Assiut university.
Assiut University
