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Trial record 21 of 2862 for:    Pancreatic Cancer AND pancreas

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

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.

Condition or disease Intervention/treatment
Pancreas Cancer Diagnostic Test: CEMIP , CA19-9 ,CEA Diagnostic Test: A) CBC . B) RBG. C)KFT. D) LFT.

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Evaluation of Cell Migration Inducing Protein (CEMIP) in Diagnosis of Pancreatic Carcinoma in Comparison With Other Traditional Markers
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
pancreatic cancer patients (50 patients)
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.

Group2
A- Non-pancreatic cancer subjects with benign diseases will be 20 subjects. B- Healthy individuals (control): 20 apparently healthy volunteers after informed consent.
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679910


Contacts
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Contact: Dina Safwat, Dr 01017897213 dina_safwat14@yahoo.com

Locations
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Egypt
Dina Mohammed Safwat Recruiting
Assiut, Egypt
Contact: Dina Mohammed, Dr    01017897213    dina_safwat14@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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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

Publications:
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Responsible Party: Dina Safwat, doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03679910     History of Changes
Other Study ID Numbers: CEMIP in pancreatic cancer
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dina Safwat, Assiut University:
CA 19-9
CEA
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases