Ignite Creation Date:
2024-05-06 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03679910
Status:
UNKNOWN
Last Update Posted:
2018-09-21
First Post:
2018-09-19
Brief Title:
Evaluation of CEMIP in Pancreatic Cancer
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Evaluation of Cell Migration Inducing Protein CEMIP in Diagnosis of Pancreatic Carcinoma in Comparison With Other Traditional Markers
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
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:
Pancreatic cancer PC is one of the most lethal diseases among all cancer types
The diagnosis of PC is usually based on radiology or invasive endoscopic techniques Various types of tumor markers are used for diagnosing PC The tumor markers carbohydrate antigen19-9 CA 19-9 and carcinoembryonic antigen CEA are the ones most closely tied to PC These tests are more often used in people already diagnosed with pancreatic cancer to help tell if treatment is working or if the cancer is progressing
Cell migration inducing protein CEMIP has been reported to be associated with early detection cancer cell migration invasion and poor prognosis
Aim of the work
To Estimate the level of CEMIP CA19-9 and CEA in pancreatic cancer patients
To evaluate the clinical utility of serum CEMIP CA19-9 and CEA in pancreatic cancer patients in comparison with healthy controls and their relation to cancer staging and histopathological types
To detect the correlation between CEMIP CA-19-9 and CEA
The diagnosis of PC is usually based on radiology or invasive endoscopic techniques Various types of tumor markers are used for diagnosing PC The tumor markers carbohydrate antigen19-9 CA 19-9 and carcinoembryonic antigen CEA are the ones most closely tied to PC These tests are more often used in people already diagnosed with pancreatic cancer to help tell if treatment is working or if the cancer is progressing
Cell migration inducing protein CEMIP has been reported to be associated with early detection cancer cell migration invasion and poor prognosis
Aim of the work
To Estimate the level of CEMIP CA19-9 and CEA in pancreatic cancer patients
To evaluate the clinical utility of serum CEMIP CA19-9 and CEA in pancreatic cancer patients in comparison with healthy controls and their relation to cancer staging and histopathological types
To detect the correlation between CEMIP CA-19-9 and CEA
Detailed Description:
Pancreas is an important retroperitoneal organ with exocrine and endocrine functions Pancreatic cancer PC is one of the most lethal diseases among all cancer types It moved from the fourth to the third leading cause of cancer-related death in the United States and is anticipated to become the second around 2020 It accounts for about 3 of all cancers in the United State and about 7 of all cancer deaths
The estimated number of PC cases in Egypt in 2013 was 2226 and it is projected to increase and be 2836 and 6883 in 2020 and 2050 respectively The overall age-adjusted PC mortality rate in Egypt was 147100000 population and analysis of the regional distribution showed significant variations in rates among provinces with Northern provinces having higher rates than Southern regions
The asymptomatic nature of early PC the lack of sensitive and specific tools to diagnose early disease and the lack of response to most forms of treatment all contribute to the high mortality rate of pancreatic cancer This poor outcome could be largely due to the late diagnosis The expression profiles of PC had been widely studied revealing several molecular factors affecting various aspects of PC
Tumors of pancreas are divided into Non-endocrine tumors which maybe benign or malignant and endocrine tumors
The diagnosis of PC is usually based on radiology computed tomography CT and magnetic resonance imaging MRI or invasive endoscopic techniques ultrasound endoscopy-fine needle aspiration EUS-FNA endoscopic retrograde cholangiopancreatography ERCP and explorative laparoscopy Imaging diagnosis method is a normal method for clinical tumor diagnosis But due to the various defects of the image device it is usually to combine several kinds of technologies for diagnosis Moreover because of the low sensitivity and specificity the methods are often used in the diagnosis of high risk groups rather than early detection Therefore it is urgently needed to develop new methods for early diagnosis of cancer
An ideal diagnostic method for PC should definitively distinguish malignant lesions from benign lesions provide precise tumor staging and detect early-stage disease and preneo-plastic conditions There are many challenges in the early detection of PC including its asymptomatic nature the lack of a characteristic radiological manifestation and the absence of specific molecules in body fluid Therefore convenient and highly sensitive diagnostic tests for screening PC are probably more important than tests with good specificity but moderate sensitivity
Various types of tumor markers are used for diagnosing PC The tumor markers carbohydrate antigen19-9CA 19-9 and carcinoembryonic antigen CEA are the ones most closely tied toPC But these proteins dont always go up when a person has pancreatic cancer and even if they do the cancer is often already advanced by the time this happens Sometimes levels of these tumor markers can go up even when a person doesnt have pancreatic cancer For these reasons CA19-9 and CEA arent used to screen for pancreatic cancer although a doctor might still order these tests if a person has symptoms that might be from pancreatic cancer These tests are more often used in people already diagnosed with pancreatic cancer to help tell if treatment is working or if the cancer is progressing
Although CA 19-9 is known as a pancreatic cancer biomarker it is not commonly used for general screening owing to its low sensitivity and specificity In particular false-negative results in the segment of the population with Lewis blood type A-B- and false-positive results in patients with obstructive jaundice limit the specificity of CA 19-9 for PC Therefore development of novel diagnostic markers is required for the early detection of PC
CEMIP KIAA1199 defined as cell migration inducing protein currently is located in chromosome 15q251 which appears in the nucleus and cytoplasm It is a secreted protein 153KDa rather than a transmembrane protein Its mutation site was reported to cause hearing loss due to the folding change of protein structure meanwhile the over-expression of CEMIP referred to dreadful invasion and uncontrolled proliferation of tumor with distant metastasis and limited survival opportunity of patients Especially over-expressed CEMIP also protected malignant tumor from strict microenvironment in hypoxia low glucose and cracked barrier leading to enhanced adaptability of tumor by stimulating the epidermal growth factor receptor EGFR fibroblast growth factor receptors FGFR pathway CEMIP plays an important role in cytokine pathway and its over-expression in tumors provide a novel target for individual therapy Targeting CEMIP would thereby dysregulate the cytokine pathway which would in turn decide the growth and death of the vicious tumor cells
Increased expression of CEMIP has been reported in various cancers including breast colorectal and gastric Several studies have investigated the role of CEMIP in pancreatic cancer It has been reported to be associated with early detection cancer cell migration invasion and poor prognosis Suh 2016 suggested that CEMIP may be useful for detecting pancreatic cancer at an early stage while Koga 2017 demonstrated its association with prognosis in PC
Primary screening using circulating biomarkers followed by confirmative diagnosis based on imaging and pathologic results might be the future strategy for diagnosing PC
The estimated number of PC cases in Egypt in 2013 was 2226 and it is projected to increase and be 2836 and 6883 in 2020 and 2050 respectively The overall age-adjusted PC mortality rate in Egypt was 147100000 population and analysis of the regional distribution showed significant variations in rates among provinces with Northern provinces having higher rates than Southern regions
The asymptomatic nature of early PC the lack of sensitive and specific tools to diagnose early disease and the lack of response to most forms of treatment all contribute to the high mortality rate of pancreatic cancer This poor outcome could be largely due to the late diagnosis The expression profiles of PC had been widely studied revealing several molecular factors affecting various aspects of PC
Tumors of pancreas are divided into Non-endocrine tumors which maybe benign or malignant and endocrine tumors
The diagnosis of PC is usually based on radiology computed tomography CT and magnetic resonance imaging MRI or invasive endoscopic techniques ultrasound endoscopy-fine needle aspiration EUS-FNA endoscopic retrograde cholangiopancreatography ERCP and explorative laparoscopy Imaging diagnosis method is a normal method for clinical tumor diagnosis But due to the various defects of the image device it is usually to combine several kinds of technologies for diagnosis Moreover because of the low sensitivity and specificity the methods are often used in the diagnosis of high risk groups rather than early detection Therefore it is urgently needed to develop new methods for early diagnosis of cancer
An ideal diagnostic method for PC should definitively distinguish malignant lesions from benign lesions provide precise tumor staging and detect early-stage disease and preneo-plastic conditions There are many challenges in the early detection of PC including its asymptomatic nature the lack of a characteristic radiological manifestation and the absence of specific molecules in body fluid Therefore convenient and highly sensitive diagnostic tests for screening PC are probably more important than tests with good specificity but moderate sensitivity
Various types of tumor markers are used for diagnosing PC The tumor markers carbohydrate antigen19-9CA 19-9 and carcinoembryonic antigen CEA are the ones most closely tied toPC But these proteins dont always go up when a person has pancreatic cancer and even if they do the cancer is often already advanced by the time this happens Sometimes levels of these tumor markers can go up even when a person doesnt have pancreatic cancer For these reasons CA19-9 and CEA arent used to screen for pancreatic cancer although a doctor might still order these tests if a person has symptoms that might be from pancreatic cancer These tests are more often used in people already diagnosed with pancreatic cancer to help tell if treatment is working or if the cancer is progressing
Although CA 19-9 is known as a pancreatic cancer biomarker it is not commonly used for general screening owing to its low sensitivity and specificity In particular false-negative results in the segment of the population with Lewis blood type A-B- and false-positive results in patients with obstructive jaundice limit the specificity of CA 19-9 for PC Therefore development of novel diagnostic markers is required for the early detection of PC
CEMIP KIAA1199 defined as cell migration inducing protein currently is located in chromosome 15q251 which appears in the nucleus and cytoplasm It is a secreted protein 153KDa rather than a transmembrane protein Its mutation site was reported to cause hearing loss due to the folding change of protein structure meanwhile the over-expression of CEMIP referred to dreadful invasion and uncontrolled proliferation of tumor with distant metastasis and limited survival opportunity of patients Especially over-expressed CEMIP also protected malignant tumor from strict microenvironment in hypoxia low glucose and cracked barrier leading to enhanced adaptability of tumor by stimulating the epidermal growth factor receptor EGFR fibroblast growth factor receptors FGFR pathway CEMIP plays an important role in cytokine pathway and its over-expression in tumors provide a novel target for individual therapy Targeting CEMIP would thereby dysregulate the cytokine pathway which would in turn decide the growth and death of the vicious tumor cells
Increased expression of CEMIP has been reported in various cancers including breast colorectal and gastric Several studies have investigated the role of CEMIP in pancreatic cancer It has been reported to be associated with early detection cancer cell migration invasion and poor prognosis Suh 2016 suggested that CEMIP may be useful for detecting pancreatic cancer at an early stage while Koga 2017 demonstrated its association with prognosis in PC
Primary screening using circulating biomarkers followed by confirmative diagnosis based on imaging and pathologic results might be the future strategy for diagnosing PC
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