HER-2 Expression in Pancreatic Duct Adenocarcinoma

September 20, 2023 updated by: Maisa Hashem Mohammed, Sohag University

Evaluation of Immunohistochemical Expression of Human Epidermal Growth Factor Receptor 2 (HER 2) and Its Association With Clinicopathological Variables in Patients With Pancreatic Duct Adenocarcinoma in Upper Egypt

Pancreatic duct adenocarcinoma is a highly aggressive carcinoma that is associated with a poor prognosis. Detection of novel biological markers that are specifically over expressed in pancreatic duct adenocarcinoma and their subsequent targeting by anti cancer therapeutic modalities may improve patient's survival.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pancreatic duct adenocarcinoma (PDAC) is a deadly neoplasm that showed current increase in its occurrence. There are many challenges in PDAC; the tumor is frequently associated with perineural invasion and angioinvasion, these lead to early metastasis.Another important challenge is that the tumor is associated with extensive fibrosis that prevents arrival of chemotherapeutic agents. Most modern anti-cancer therapeutic modalities depend on the biologic signature of the tumor. Human epidermal growth factor receptor-2 (HER-2) is a cell surface protein that is associated with enhanced cellular proliferation. HER-2 has been detected and successfully targeted in many human carcinomas as breast and gastric cancers. we aimed to evaluate the potential cancer-promoting effect of HER-2 in PDAC, in order to detect any possible benefits of its targeting by future therapeutic modalities.

Study Type

Observational

Enrollment (Actual)

37

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

Sampling Method

Probability Sample

Study Population

• This study will be performed on archived formalin-fixed, paraffin-embedded tissue blocks that belonged to 37 patients who were admitted to Assuit and Sohag Oncology Centers and Sohag university hospital from January, 1st, 2017 to December, 31st, 2020. Patients' complaints included obstructive jaundice, abdominal pain and vomiting. Radiological assessment revealed heterogeneous suspicious pancreatic lesions from which tru-cut biopsies were obtained and examined by the standard staining method; hematoxylin and eosin (H&E). Cases diagnosed as pancreatic carcinoma on the basis of tru-cut biopsies underwent pancreaticoduodenectomy (Whipple procedure) or distal pancreatectomy, depending on tumor location.

Description

Inclusion Criteria:

  1. Cases of PDAC who underwent radical operations.
  2. Tissue blocks with sufficient material.
  3. Cases with available clinical data.

Exclusion Criteria:

  1. Cases of pancreatic carcinoma other than PDAC.
  2. Patients who received preoperative chemotherapy or radiotherapy.
  3. Patients with PDAC who were diagnosed by tru-cut biopsies only and didn't undergo radical operations.
  4. Cases with insufficient/destructed material.
  5. Patients with inadequate clinical data.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of HRE-2 expression with clinical and pathological parameters
Time Frame: 6 months
levels of HER-2 expression will be correlated with clinical parameters (as patients' ages, sexes, tumor location), and pathological parameters (as tumor grades, stages, neural and vascular invasion).
6 months

Collaborators and Investigators

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

Sponsor

Sohag University

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 (Actual)

January 1, 2017

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-09-4PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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