HER-2 Expression in Pancreatic Duct Adenocarcinoma

Sponsor

Sohag University (Other)

Overall Status

Completed

CT.gov ID

NCT06055647

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Adenocarcinoma	Genetic: immunohistochemical approach

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 Design

Study Type:

Observational

Actual Enrollment :

37 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Aug 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

correlation of HRE-2 expression with clinical and pathological parameters [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maisa Hashem Mohammed, Maisa H Mohammed, MD, Sohag University

ClinicalTrials.gov Identifier:

NCT06055647

Other Study ID Numbers:

Soh-Med-23-09-4PD

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maisa Hashem Mohammed, Maisa H Mohammed, MD, Sohag University

HER-2

Pancreatic Duct Adenocarcinoma

Immunohistochemistry

Additional relevant MeSH terms:

Adenocarcinoma

Carcinoma, Ductal

Study Results

No Results Posted as of Sep 28, 2023