Updates and Insights on HER2 in Breast Cancer in Sohag Governorate

NCT07758127 | Not Yet Recruiting

• 1 other identifier: Soh-Med26-7-22MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

• To evaluate HER2 expression in breast carcinoma with emphasizing HER2-ultralow, and HER2-low, HER2 equivocal tumors.
• To correlate the results of HER2 with clinico-pathological prognostic parameters; examples tumor grade, Ki-67 proliferation index, nodal status, tumor size, lympho-vascular invasion, and perineural invasion, tumor infiltrating lymphocytes
• To access interobserval agreement in HER2 score interpretation

Conditions

HER2 Status in Breast Cancer

Keywords

HER2

Outcome Measures

Primary Outcomes (1)

• HER2 status in breast cancer

  To evaluate the HER2 status among breast cancer patients diagnosed at Sohag Oncology center using immunohistochemistry (IHC) and, when indicated, in situ hybridization (ISH), and to describe the distribution of HER2 expression.

  2025/2026

Study Arms (1)

Breast cancer female patients

Female patients with histopathologically confirmed breast cancer diagnosed at Sohag Oncology center during 2025-2026. Archived formalin-fixed paraffin-embedded tissue samples and pathology records will be retrospectively reviewed to evaluate HER2 status by immunohistochemistry (IHC)

Eligibility Criteria

• Age: 26 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes female patients with histopathologically confirmed breast cancer diagnosed at Sohag Oncology center during the study period (2025-2026). Archived formalin-fixed paraffin-embedded tissue blocks and corresponding pathology records will be retrospectively reviewed to evaluate HER2 status. Only cases meeting the eligibility criteria will be included.

You may qualify if:

• \) Breast cancer cases diagnosed during 2025 and 2026. 2) Cases with available HER2 immunohistochemical results. 3) Cases with sufficient tissue material for evaluation. 4) Cases with complete clinical and follow-up data. 5) Cases that were accessible for pathologic review

You may not qualify if:

• Cases with insufficient, destroyed, necrotic, or unavailable tissue blocks.
• Cases with incomplete clinical information.
• Cases lacking adequate immunohistochemical assessment.
• Cases outside the study period

Sponsors & Collaborators

• Sohag University: lead
• Sohag Oncology Center: collaborator

Study Sites (1)

Faculty of medicine sohag university

Sohag, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

archived formalin-fixed, paraffin-embedded tissue blocks

Central Study Contacts

Dr. Fatma El-Zahraa Prof. Dr. Fatma El-Zahraa Salah El-Deen Safe El-Deen, Professor of Pathology

CONTACT

01007970144; fatmafm2002@yahoo.com

Dr. Ola Dr. Ola Mohamed Nageeb Mazeed, Lecturer of Pathology

CONTACT

01005156672; Olaamohamed@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pathology resident at Sohag Oncology Center

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

EG (1)