Adults 6 Months to 1, female only, with Ovarian Neoplasms or Germ Cell Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
P16 Evaluation in Ovarian Germ Cell TumorsPrimary· 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 multiplyi
P16 cytoplasmic expression
Group
Value
95% CI
Malignant Ovarian Germ Cell Tumors ( MOGCTs).
7
0 – 8
Mature Cystic Teratomas.
4
0 – 6
Normally Apparent Ovaries.
0
0 – 4
P16 nuclear expression
Group
Value
95% CI
Malignant Ovarian Germ Cell Tumors ( MOGCTs).
6
0 – 8
Mature Cystic Teratomas.
4
0 – 5
Normally Apparent Ovaries.
0
0 – 3
Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.Primary· 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.
Group
Value
95% CI
Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.
15
0 – 100
Correlation Between P16 Cytoplasmic Score and FIGO Staging of MOGCTs.Secondary· After obtaining of results and collecting raw data , within 2 months.
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 exa
Group
Value
95% CI
Malignant Ovarian Germ Cell Tumors ( MOGCTs).
11
9.5 – 13.5
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Assiut University
Last refreshed: 8 September 2021
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