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临床试验/NCT03692533
NCT03692533Unknown不适用

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

Assiut University0 个研究点目标入组 80 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
主要终点
Number of participants that develops Tumor metastasis as assessed by Multi slice CT

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group A

Active Comparator

Group (A) [study cases] Adult patients who will undergo radical or partial nephrectomy.for primary renal cell carcinoma.

干预措施: Immunohistochemistry (Diagnostic Test)

Group B

Active Comparator

Group (B) [control cases] Adult patients who will undergo simple nephrectomy for benign causes

干预措施: Immunohistochemistry (Diagnostic Test)

结局指标

主要结局

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

时间窗: 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

时间窗: 2 years

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Abdelghany Allam

Assistant lecturer

Assiut University

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