Clinical trial · Observational
Immunohistochemical Evaluation of Protein P16 Expression in Ovarian Germ Cell Tumors.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Tumors | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Immunohistochemistry | — | UNRESOLVED | — |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ki67 antibody (DAKO) for malignant cases only | Combination Product | — | UNRESOLVED |
| p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267) | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Malignant ovarian germ cell tumors ( MOGCTs).
- description
- 22 cases of malignant ovarian germ cell tumors ; include Dysgerminoma , yolk sac tumor and immature teratomas will be treated by anti P16 antibody and Ki67 antibody.
- interventionNames
- Combination Product: p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267)
- Combination Product: Ki67 antibody (DAKO) for malignant cases only
- label
- Mature cystic teratomas.
- description
- 20 cases of mature teratomas will be treated by anti P16 antibody .
- interventionNames
- Combination Product: p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267)
- label
- Normally apparent ovaries.
- description
- 20 cases of normally apparent ovaries will be treated by anti P16 antibody .
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 6 Months
- Maximum age
- 1 Year
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available