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

NCT04283773 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2021-09-08

Study results available
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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.

Conditions

  • Ovarian Neoplasms
  • Germ Cell Tumors
  • Immunohistochemistry

Interventions

COMBINATION_PRODUCT

p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267)

Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).

COMBINATION_PRODUCT

Ki67 antibody (DAKO) for malignant cases only

Treatment of slides that cut from paraffin embedded blocks related to malignant case group by immunohistochemical method by Ki67 antibody.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Omar Ahmed, Master · Pathology department- Faculty of medicine - Assiut university

Eligibility

Min Age
6 Months
Max Age
1 Year
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-24
Primary Completion
2021-04-01
Completion
2021-04-01
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04283773 on ClinicalTrials.gov