ITGA2b and SELP Expression in Cancer Pancreas and Biliary Tract Cancer

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05493878
Collaborator
(none)
128
14

Study Details

Study Description

Brief Summary

  1. To study the expression pattern of Integrin alpha 2b (ITGA2b) and Selectin P (SELP) genes of Tumor educated platelets in pancreatic and biliary tree cancer and its diagnostic value.

  2. To investigate correlation between expression levels of ITGA2b and SELP genes and stages of pancreatic and biliary tree cancer.

  3. To investigate correlation between expression levels of ITGA2b, SELP genes, CA 19-9 and CEA in pancreatic and biliary tree cancer patients.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: mRNA expression

Detailed Description

Malignant tumors arising in the biliary tract and pancreas are aggressive malignancies characterized by a poor prognosis and most of cases are diagnosed at advanced stages and have poor outcome . The most common pancreatic cancer is ductal adenocarcinoma, which accounts for about 80% of all pancreatic cancers. Pancreatic cancer is a highly lethal gastrointestinal cancer with a low 5-year survival rate and difficulty in early detection . Biliary tract cancers can be divided into intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer. CEA and CA 19-9 are the most common used serum biomarker for cancer screening and the diagnosis of pancreatic and biliary cancer.

Platelets are an essential component of the tumor microenvironment and serve as local and systemic respondents during tumor initiation and tumor metastasis. After interaction with tumor cells or tumor associated biomolecules, platelets can alter their RNA profile, and this process give rise to the so-called tumor educated platelets (TEPs). Tumor cells can directly and indirectly produce changes on platelet RNA and protein content, emerging a new term called liquid biopsy which reflect the presence of cancer and thus give hope to many that they might precede protein markers as a cancer-specific biomarker. Alterations in the TEPs RNA profile have been described as a novel source of potential biomarkers and can be used for early detection of cancer and treatment monitoring. Platelet biomarker transcripts can be transferred from tumor cells to platelets, although in some studies, the putative origin of the biomarker is the megakaryocyte (endogenous).

Integrin Alpha 2b (ITGA2b) gene encodes a member of the integrin alfa chain family of proteins which is proteolytically processed to form subunit of the alpha-IIb/beta-3 integrin cell adhesion receptor which is play crucial role in the blood coagulation system, by mediating platelets aggregation . Selectin P (SELP) gene encodes a protein that is stored in the alpha granules of platelets and Weibel-Palade bodies of endothelial cells. This protein redistributes to the plasma membrane during platelet activation and degranulation and mediates the interaction of activated endothelial cells or platelets with leukocytes. ITGA2b and SELP are cancer related genes and of the mRNA TEPs putative endogenous biomarkers which have a high value for detection of cancer, so, tumor educated platelets (TEPs) broadened the spectrum of liquid biopsy applications, and may enable blood-based cancer diagnostics.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
128 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Diagnostic Value of Tumor-Educated Platelets Integrin Alpha 2b (ITGA2B) and Selectin P (SELP) mRNA Expression in Pancreatic and Biliary Tract Cancer
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Expression levels of ITGA2b and SELP on Tumor Educated PLatelets for diagnosis of pancreatic and biliary cancer [Baseline]

    To study the expression pattern of ITGA2b and SELP genes of Tumor educated platelets in pancreatic and biliary tree cancer and its diagnostic value.

Secondary Outcome Measures

  1. Correlation between expression levels of ITGA2b and SELP on TEPs and the commonly used tumour marker CEA and CA 19-9 in the diagnosis of pancreatic and biliary cancer. [Baseline]

    3- To investigate correlation between expression levels of ITGA2b, SELP genes, CA 19-9 and CEA in pancreatic and biliary tree cancer patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients diagnosed pathologically as pancreatic and biliary cancer by gold standard test (pancreatic and biliary tract biopsy by endoscopy), male or female at any age.
Exclusion Criteria:
  • History of anti-neoplastic therapy, such as chemotherapy or radiotherapy.

  • Any other types of cancers.

  • Any other clinically systemic acute or chronic inflammatory disease/s within one months.

  • Autoimmune diseases.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Ola A Afifi, doctor, Ola A Afifi
  • Study Chair: Fatma M Helbawi, doctor, Fatma M Helbawi

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Amany Hamdy Radwan, Doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05493878
Other Study ID Numbers:
  • TEPs genes in cancer pancrease
First Posted:
Aug 9, 2022
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amany Hamdy Radwan, Doctor, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022