N/A
N=62
Immunohistochemical Evaluation of Protein P16 Expression in Ovarian Germ Cell Tumors.
Ovarian Neoplasms · Germ Cell Tumors · Immunohistochemistry
Bottom Line
View on ClinicalTrials.gov: NCT04283773 ↗Enrolled (actual)
62
Serious AEs
—
Results posted
Sep 2021
Primary outcome: Primary: P16 Evaluation in Ovarian Germ Cell Tumors — 7; 4; 0; 6 units on a scale — p=0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267) (Combination_product); Ki67 antibody (DAKO) for malignant cases only (Combination_product)
- Age
- Pediatric · 0+ yrs
- Sex
- Female
- Sponsor
- Assiut University
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY P16 Evaluation in Ovarian Germ Cell Tumors |
7; 4; 0; 6; 4; 0 | 0.001 sig |
| PRIMARY Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors. |
15 | 0.009 sig |
| SECONDARY Correlation Between P16 Cytoplasmic Score and FIGO Staging of MOGCTs. |
11 | 0.699 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 .
Exclusion Criteria
- Epithelial ovarian tumors
- sex cord -stromal ovarian tumors.
- metastatic ovarian lesions.
Data sourced from ClinicalTrials.gov (NCT04283773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.