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

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ClinicalTrials.gov Identifier: NCT04283773
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Omar A Ahmed, Assiut University

Brief Summary:

Ovarian germ cell tumors (OGCTs) constitute 10% of ovarian tumors in Egypt [1] and mainly affect young females [2].Teratomas are the most common type [3].Most of teratomas is benign. However, it is liable for malignant transformation [4]. Others are malignant including dysgerminoma, immature teratoma, yolk sac tumor,.etc.[5] and accounts 1-1.5% of cancers in young females [6]. The pathogenesis of OGCTs is not clearly understood. Some authors revealed that mature cystic teratoma is a form of human parthenogenesis [7], which makes important concerns about future of fertility and germ stem cell replacement therapy [8].

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 [9]. CDK inhibitors now are evolving as novel target therapies under clinical trials such as Palbociclib, Abemaciclib and Ribociclib that offer a hope for different cancers, such as breast cancer [10] and non-small cell lung cancer [11].One member which is recently approved by US FDA is palbociclib for use in postmenopausal women with breast cancer [12].Thus, it is necessary to do further researches on its expression among different neoplasms.

P16 immunohistochemical(IHC) expression has been widely investigated in different cancers. Its IHC expression is either absent [13] or overexpressed [14] .Overexpression of p16 is documented in Human Papilloma Virus related endocervical neoplasms and High grade squamous intraepithelial lesions of the vulvovaginal region [14].Absence of p16 expression is detected in multiple cancers such as Lung cancer, colorectal cancer and lymphoma [15].

P16 IHC expression in OGCTs is poorly investigated. One study suggests that absent p16 is involved in proliferation of malignant OGCTs via molecular assessment[16].Another study suggested that decrease P16 is involved in malignant transformation of Mature cystic teratoma to squamous cell carcinoma [17].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. Abnormalities may be found either in neoplastic or stromal components. The role of stromal component of OGCTs as tumor microenvironment has no published studies yet.

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 and new advances in use of germ stem cell replacement therapy.


Condition or disease Intervention/treatment
Ovarian Neoplasms Diagnostic Test: Immunohistochemistry

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Immunohistochemical Evaluation of Protein P16 Expression in Ovarian Germ Cell Tumors.
Actual Study Start Date : December 24, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer


Intervention Details:
  • Diagnostic Test: Immunohistochemistry
    Immune staining for slides of both control cases of normally apparent ovaries and cases of ovarian germ cell tumors of different types : benign ( mature cystic teratoma) and malignant ( immature teratoma ,yolk sac tumor and dysgerminoma).


Primary Outcome Measures :
  1. Evaluation of P16 in ovarian neoplasms [ Time Frame: 1 year ]
    Evaluation of the immunohistochemical expression of protein P 16 in different types of ovarian germ cell tumors in both neoplastic and stromal components.


Secondary Outcome Measures :
  1. Correlation with clinical features. [ Time Frame: 1 year. ]
    Correlate between P16 immunohistochemical expression with clinicopathological parameters (Age, Histopathological type, grading, and staging).


Biospecimen Retention:   Samples Without DNA

Formalin fixed paraffin embedded blocks of eighty ovarian specimens will be included in this study. These specimens will be divided into 2 groups:

  1. Forty surgically resected ovarian germ cell tumors specimens: twenty malignant ones( dysgerminoma , immature teratoma and yolk sac tumor) as a case group and equal twenty benign ones (mature cystic teratoma ) as comparison group with mean age 17 years old.
  2. Forty normally apparent ovaries that surgically resected with specimens of total abdominal hysterectomy and salpingo-Oopherctomy for non-ovarian causes in perimenopausal women as a control group with mean age 40 years old.


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Ages Eligible for Study:   6 Months to 1 Year   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Formalin fixed paraffin embedded blocks of eighty ovarian specimens will be included in this study. These specimens will be divided into 2 groups:

  1. Forty surgically resected ovarian germ cell tumors specimens: twenty malignant ones( dysgerminoma , immature teratoma and yolk sac tumor) as a case group and equal twenty benign ones (mature cystic teratoma ) as comparison group with mean age 17 years old.
  2. Forty normally apparent ovaries that surgically resected with specimens of total abdominal hysterectomy and salpingo-opherctomy for non-ovarian causes in perimenopausal women as a control group with mean age 40 years old.
Criteria

Inclusion Criteria:

  • Ovarian germ cell tumors :

    1. benign ( mature cystic teratoma ).
    2. malignant ones ( dysgerminoma , immature teratoma and yolk sac tumor).

Exclusion Criteria:

  1. Epithelial ovarian tumors
  2. sex cord -stromal ovarian tumors.
  3. metastatic ovarian lesions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283773


Contacts
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Contact: Omar Ahmed, Master 00201033986747 omarahmedali6@gmail.com

Locations
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Egypt
Assiut University Recruiting
Assiut, Egypt, 71111
Contact: Omar Ahmed, Master    00201033986747    omarahmedali6@gmail.com   
Sponsors and Collaborators
Assiut University
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Treatment outcomes of female germ cell tumors: The Egyptian National Cancer Institute experience. Journal of the Egyptian National Cancer Institute
Study Protocol  This link exits the ClinicalTrials.gov site
Incidence and Survival Rates for Female Malignant Germ Cell Tumors
Study Protocol  This link exits the ClinicalTrials.gov site
Ovarian Teratomas: Tumor Types and Imaging Characteristics
Study Protocol  This link exits the ClinicalTrials.gov site
Early diagnosis of malignant-transformed ovarian mature cystic teratoma: fat-suppressed MRI findings

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Responsible Party: Omar A Ahmed, Demonstrator at Pathology department - faculty of medicine - Assiut university., Assiut University
ClinicalTrials.gov Identifier: NCT04283773    
Other Study ID Numbers: 17100871
2019-09-05-001-R1 ( Other Grant/Funding Number: Grant office - faculty of medicine - Assiut university )
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Omar A Ahmed, Assiut University:
OGCTs, P16 , IHC
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Ovarian Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders