Ignite Creation Date:
2024-05-06 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03692533
Status:
UNKNOWN
Last Update Posted:
2018-10-02
First Post:
2018-09-20
Brief Title:
Role of Geminin and Mcm-2 in Prognosis of Renal Cell Carcinoma
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Role of Immunohistochemical Markers Geminin and Mcm2 in Prognosis of Renal Cell Carcinoma and Its Clinicopathological Correlation A Prospective Controlled Study
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 338000 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 neutrophillymphocyte 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
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 neutrophillymphocyte 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None