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Clinical Trials/NCT03692533
NCT03692533
Unknown
Not Applicable

Role of Immunohistochemical Markers , Geminin and Mcm2 in Prognosis of Renal Cell Carcinoma, and Its Clinicopathological Correlation. A Prospective Controlled Study

Assiut University0 sites80 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Cell Carcinoma
Sponsor
Assiut University
Enrollment
80
Primary Endpoint
Number of participants that develops Tumor metastasis as assessed by Multi slice CT
Last Updated
7 years ago

Overview

Brief Summary

The study aim is to prospectively assess the prognostic significance of immunohistochemical markers Geminin and Mcm-2 in cases of renal cell carcinoma and to detect its clinicopathological correlation.

Detailed Description

Renal cell carcinoma (RCC) is one of the most common urological malignancies. Approximately 338,000 people are diagnosed with RCC worldwide each year, representing approximately 2-3 % of all cancers. RCC can be classified into non-epithelial and epithelial, according to cell origin. The four major types are of epithelial origin includes: clear cell renal carcinoma (ccRCC), papillary, chromophobe renal carcinoma (chRCC) and collecting duct carcinoma. The most common subtype of RCC is ccRCC which accounts for approximately 70-80% of all renal cell carcinomas. Prognostic factors for RCC can be classified into: anatomical, histological, clinical, and molecular factors. Anatomical factors include tumor size, venous invasion, renal capsular invasion, adrenal involvement, Lymph node and distant metastasis. Histological factors include tumour grade, RCC subtype, sarcomatoid features, microvascular invasion, tumour necrosis, and invasion of the collecting system. Clinical factors include performance status, local symptoms, cachexia, anaemia, platelet count, neutrophil/lymphocyte ratio, C-reactive protein (CRP) and serum albumin. As regard the molecular factors, numerous markers such as carbonic anhydrase IX, vascular endothelial growth factor (VEGF), hypoxia-inducible factor (HIF), Ki67, PTEN (phosphatase and tensin homolog), osteopontin and other cell cycle and proliferative markers are being investigated. The efficiency and accuracy of biomarkers studies using immunohistochemical and tissue microarray techniques are still variable and unclear in regards to prognostic significance in patients with renal tumors. Multiple biomarkers shown to be significant to assess diagnosis and prognosis in these patients and other were not significant. In the RCC cell cycle, minichromosome maintenance 2 (Mcm2), Geminin define the proliferative state. Investigators are able to determine differential levels of expression of various markers in normal tissue compared with indolent and aggressive tumors. Among platforms used in determining the presence of biological markers in surgical pathology specimens, immunohistochemistry is perhaps the most commonly available tool in the routine diagnostic laboratory. Immunohistochemistry allows detection of antigens expressed on tumor cells, hence permitting characterization of the tumor. This study was designed to assess the prognostic significance of Geminin and Mcm-2 in cases of renal cell carcinoma and to assess its clinicopathological correlation.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
December 1, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Abdelghany Allam

Assistant lecturer

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of participants that develops Tumor metastasis as assessed by Multi slice CT

Time Frame: 2 years

Number of patients that develops tumor metastasis after partial or radical nephrectomy as diagnosed by Multi slice CT will be assessed

Number of participants that develops recurrence of tumor as assessed by Multi slice CT

Time Frame: 2 years

Number of patients that develops recurrent tumor after partial or radical nephrectomy as diagnosed by Multi slice CT will be assessed

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