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Trial record 13 of 2837 for:    Pancreatic Cancer

Evaluation of CEMIP in Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03679910
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dina Safwat, Assiut University

Tracking Information
First Submitted Date September 19, 2018
First Posted Date September 21, 2018
Last Update Posted Date September 21, 2018
Estimated Study Start Date January 1, 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 19, 2018)
Diagnostic value of cell migration inducing protein (CEMIP) in serum of pancreatic cancer as non invasive marker. [ Time Frame: 2 day ]
Measurement of CEMIP by enzyme linked immunosorbent assay (ELISA) in serum of pancreatic cancer patients.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of CEMIP in Pancreatic Cancer
Official Title Evaluation of Cell Migration Inducing Protein (CEMIP) in Diagnosis of Pancreatic Carcinoma in Comparison With Other Traditional Markers
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.
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 2,226, and it is projected to increase and be 2,836 and 6,883 in 2020 and 2050 respectively. The overall age-adjusted PC mortality rate in Egypt was 1.47/100,000 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 antigen19-9(CA 19-9) and carcinoembryonic antigen (CEA) are the ones most closely tied toPC. But these proteins don't 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 doesn't have pancreatic cancer. For these reasons, CA19-9 and CEA aren't 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 15q25.1, 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 confir¬mative diagnosis based on imaging and patho¬logic results might be the future strategy for diagnosing PC.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will be conducted on 90 informed individuals (according to the guidelines of ethical committee of faculty of Medicine, Assiut University and South Egypt Cancer Institute).
Condition Pancreas Cancer
Intervention
  • Diagnostic Test: CEMIP , CA19-9 ,CEA
    CEMIP: Cell migration inducing protein CA19-9: Carbohydrate antigen 19-9 CEA: Carcinoembryonic antigen
  • Diagnostic Test: A) CBC . B) RBG. C)KFT. D) LFT.
    A)CBC: Complete blood count. B)RBG: Random blood glucose. C)KFT: Kidney function tests. D)LFT: Liver function tests.
Study Groups/Cohorts
  • Group 1
    pancreatic cancer patients (50 patients)
    Interventions:
    • Diagnostic Test: CEMIP , CA19-9 ,CEA
    • Diagnostic Test: A) CBC . B) RBG. C)KFT. D) LFT.
  • Group2
    A- Non-pancreatic cancer subjects with benign diseases will be 20 subjects. B- Healthy individuals (control): 20 apparently healthy volunteers after informed consent.
    Interventions:
    • Diagnostic Test: CEMIP , CA19-9 ,CEA
    • Diagnostic Test: A) CBC . B) RBG. C)KFT. D) LFT.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 19, 2018)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Group 1:

Includes all patients presented by pancreatic cancer with clinical, radiological, laboratory diagnosis and pathological diagnosis.

Group 2:

A: Healthy individual B: Individual with benign diseases such as benign hepatopancreatobiliary conditions as gall stones, obstructive calcular jaundice, chronic pancreatitis and benign gasrtrointestinal as ulcer and polyp.

Exclusion Criteria:

  • Patients recently operated for pancreatic cancer.
  • patients diagnosed to have another type of cancer (Breast, gastric or colorectal).
  • High risk group of another type of cancer.
  • Patients with disseminated cancer.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Dina Safwat, Dr 01017897213 dina_safwat14@yahoo.com
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03679910
Other Study ID Numbers CEMIP in pancreatic cancer
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Dina Safwat, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Principal Investigator: Ahmed Kamel, MD Assiut University
Study Chair: Omnia Abd El Monaem, MD Assiut University
Study Chair: Randa Ahmed, MD Assiut University
Study Director: Dina Mohammed, Dr Assiut University
PRS Account Assiut University
Verification Date September 2018