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Immunohistochemical Evaluation of Protein P16 Expression in Ovarian Germ Cell Tumors.

NCT04283773CompletedOBSERVATIONAL

Summary

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.

Key Facts

Lead Sponsor

Assiut University

Enrollment

Start Date

2019-12-24

Completion Date

2021-04-01

Study Type

OBSERVATIONAL

Official Title

Immunohistochemical Evaluation of Protein P16 Expression in Ovarian Germ Cell Tumors.

Interventions

p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267)Ki67 antibody (DAKO) for malignant cases only

Conditions

Ovarian NeoplasmsGerm Cell TumorsImmunohistochemistry

Eligibility

Age Range

6 Months – 1 Year

Sex

FEMALE

Inclusion Criteria:

* Ovarian germ cell tumors :

  1. 20 benign ( mature cystic teratoma ).
  2. 22 malignant ones ( 5 dysgerminoma , 8 immature teratoma and 9 yolk sac tumor).
  3. 20 Normal ovaries .

Exclusion Criteria:

1. Epithelial ovarian tumors
2. sex cord -stromal ovarian tumors.
3. metastatic ovarian lesions.

Outcome Measures

Primary Outcomes

P16 Evaluation in Ovarian Germ Cell Tumors

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).

Time frame: Antibody exposure overnight, assessed up to 3 days for each run of sections assessed.

Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.

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.

Time frame: Antibody exposure 2 hrs , assessed up to 1 day for each run of sections assessed.

Secondary Outcomes

Correlation Between P16 Cytoplasmic Score and FIGO Staging of MOGCTs.

P16 cytoplasmic score is assessed by German quantitative scoring system by multiplying scores of intensity of staining ( 0= No , 1= weak , 2= moderate , 3 = strong ) in scores of intensity of staining ( 0 = less than 10% , 1= 11- 20 % , 2= 21-50 % , 3= 51-80% , 4= more than 80%) to induce final scores range between ( 0, 1,2,4,6,8,9 and 12). FIGO staging system for ovarian tumors between Stage I ( limited to ovaries) , II ( with pelvic extension) , III ( with peritoneal extension) and IV ( distant metastasis) , and it is reported from medical records of patients. One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . Data was expressed as mean (SD). A p-value \< 0.05 was considered significant.

Time frame: After obtaining of results and collecting raw data , within 2 months.

Locations

Assiut University, Asyut, Egypt

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.