Evaluation of CEMIP in Pancreatic Cancer

NCT03679910 | Unknown

• 1 other identifier: CEMIP in pancreatic cancer
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer

Keywords

CA 19-9; CEA

Outcome Measures

Primary Outcomes (1)

• Diagnostic value of cell migration inducing protein (CEMIP) in serum of pancreatic cancer as non invasive marker.

  Measurement of CEMIP by enzyme linked immunosorbent assay (ELISA) in serum of pancreatic cancer patients.

  2 day

Study Arms (2)

Group 1

pancreatic cancer patients (50 patients)

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.

Diagnostic Test: CEMIP , CA19-9 ,CEA; Diagnostic Test: A) CBC . B) RBG. C)KFT. D) LFT.

Interventions

CEMIP , CA19-9 ,CEA DIAGNOSTIC_TEST

CEMIP: Cell migration inducing protein CA19-9: Carbohydrate antigen 19-9 CEA: Carcinoembryonic antigen

Group 1; Group2

A) CBC . B) RBG. C)KFT. D) LFT. DIAGNOSTIC_TEST

A)CBC: Complete blood count. B)RBG: Random blood glucose. C)KFT: Kidney function tests. D)LFT: Liver function tests.

Group 1; Group2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Dina Mohammed Safwat

Asyut, Egypt

RECRUITING

Related Publications (3)

• Lee HS, Jang CY, Kim SA, Park SB, Jung DE, Kim BO, Kim HY, Chung MJ, Park JY, Bang S, Park SW, Song SY. Combined use of CEMIP and CA 19-9 enhances diagnostic accuracy for pancreatic cancer. Sci Rep. 2018 Feb 21;8(1):3383. doi: 10.1038/s41598-018-21823-x.

  PMID: 29467409 BACKGROUND

• Koga A, Sato N, Kohi S, Yabuki K, Cheng XB, Hisaoka M, Hirata K. KIAA1199/CEMIP/HYBID overexpression predicts poor prognosis in pancreatic ductal adenocarcinoma. Pancreatology. 2017 Jan-Feb;17(1):115-122. doi: 10.1016/j.pan.2016.12.007. Epub 2016 Dec 18.

  PMID: 28012880 BACKGROUND

• Li L, Yan LH, Manoj S, Li Y, Lu L. Central Role of CEMIP in Tumorigenesis and Its Potential as Therapeutic Target. J Cancer. 2017 Jul 20;8(12):2238-2246. doi: 10.7150/jca.19295. eCollection 2017.

  PMID: 28819426 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Liver Function Tests

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ahmed Kamel, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Omnia Abd El Monaem, MD

  Assiut University

  STUDY CHAIR

• Randa Ahmed, MD

  Assiut University

  STUDY CHAIR

• Dina Mohammed, Dr

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Dina Safwat, Dr

CONTACT

01017897213; dina_safwat14@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 21, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 21, 2018

Record last verified: 2018-09

Locations

EG (1)