CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267) +1 morecombination
Likely dose
Not stated in record
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Search/NCT04283773
NCT04283773N/ACompleted

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

Assiut University·observational·Posted Feb 25, 2020·Updated Sep 8, 2021

In Brief

An observational study evaluating p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267) and Ki67 antibody (DAKO) for malignant cases only for Ovarian Neoplasms and 2 related conditions. Completed, enrolled 62 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 25, 2020
Enrollment StartDec 24, 2019
Primary CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.4 years ago

Interventions

p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267)combination

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

Ki67 antibody (DAKO) for malignant cases onlycombination

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