Role of Geminin and Mcm-2 in Prognosis of Renal Cell Carcinoma

赞助:

合作者:

信息的提供 (责任方):

Mohamed Abdelghany Allam，Assiut University

追踪信息

首次提交日期 ^ICMJE

September 20, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

October 1, 2018

预计主要完成日期

October 1, 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

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

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

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

[ Time Frame: ]

描述性信息

简略标题 ^ICMJE

Role of Geminin and Mcm-2 in Prognosis of Renal Cell Carcinoma

正式标题 ^ICMJE

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

简要概况

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.

详细说明

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.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Non-Randomized
干预模型: Parallel Assignment
干预模型描述: 2 groups : Group A include cases and Group B includes controls
盲法: Interventional
盲法描述:
主要目的: Diagnostic

适用条件 ^ICMJE

干预项目 ^ICMJE

Diagnostic Test: Immunohistochemistry
Histopathological study and evaluation: For each case, the tissue samples will be evaluated by the pathologist for detecting the histopathology and in cases of malignant renal spicemens the pathologist will also assess the histologic type, Fuhrman nuclear grade, cellular invasion of perinephric fat, and the extent of any vascular invasion seen by microscopy. Immunohistochemistry: Immunohistochemical staining will be performed by using the following antibodies: Geminin and Minichromosome maintenance-2 (MCM-2). Evaluation of the immunohistochemical staining will be performed by light microscopy. The interpretation of immuno-reactivity will be performed in a quantitative manner by analyzing the extent of the staining positivity of the tumor cells. Immuno-staining of greater than 10% of tumor cells is required for scoring as a positive case.

研究工具

Active Comparator: Group A
Group (A) [study cases] Adult patients who will undergo radical or partial nephrectomy.for primary renal cell carcinoma.
Active Comparator: Group B
Group (B) [control cases] Adult patients who will undergo simple nephrectomy for benign causes

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 1, 2020

预计主要完成日期

October 1, 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion criteria: - Adult patients who will undergo radical or partial nephrectomy for primary Renal cell carcinoma (Group A). - Adult patients who will undergo simple nephrectomy for benign causes (Group B). Exclusion criteria: - Patients with secondary renal metastasis. - Patients with metastatic spread at time of presentation or operation. - Patients with renal urothelial carcinomas. - Children with renal tumors (less than 18 years). - Patients who are unfit for surgical treatment. - Patients who are refusing surgical treatment.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Mohamed Abdelghany Allam，Assiut University

研究赞助商 ^ICMJE

Assiut University

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

Assiut University

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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