ITGA2b and SELP Expression in Cancer Pancreas and Biliary Tract Cancer

August 8, 2022 updated by: Amany Hamdy Radwan, Assiut University

Diagnostic Value of Tumor-Educated Platelets Integrin Alpha 2b (ITGA2B) and Selectin P (SELP) mRNA Expression in Pancreatic and Biliary Tract Cancer

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted at clinical pathology department, Assiut University Hospital, Faculty of medicine, Assiut University. Patient will be recruited from out patient clinics and in patients of the oncology department in Assiut university. 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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression levels of ITGA2b and SELP on Tumor Educated PLatelets for diagnosis of pancreatic and biliary cancer
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline
3- To investigate correlation between expression levels of ITGA2b, SELP genes, CA 19-9 and CEA in pancreatic and biliary tree cancer patients.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

August 7, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEPs genes in cancer pancrease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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