HER-2 Expression in Pancreatic Duct Adenocarcinoma

Pancreatic Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06055647
• Other study ID #: Soh-Med-23-09-4PD
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2023
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Ductal
• Pancreatic Adenocarcinoma

Intervention

Genetic:
• immunohistochemical approach
Formalin-fixed, Paraffin-embedded tissue blocks of pancreatic duct adenocarcinoma will be stained by anti HER-2, by immunohistochemical approach.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of HRE-2 expression with clinical and pathological parameters	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