Phosphatidylinositol Glycan Anchor Biosynthesis Class U Protein in Breast Cancer

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT07130162
• Lead Sponsor: Assiut University

Brief Summary

The present study aims to evaluate the serum level of PIGU protein in patients with breast cancer and its relation with clinical, laboratory and pathological data of the patients.

Detailed Description

Breast cancer (BC) is the most common cancer among females. It is known to be the second leading cause of cancer-related deaths among women worldwide . Although the incidence rates of breast cancer vary between developed and developing nations, it continues to be the most prevalent form of cancer among women in Egypt, with an estimated mortality rate of approximately 11% in 2020 . Breast cancer is a heterogeneous disease, so treatment and prognosis vary based on tumor pathological type, histological grade, lymph node involvement, hormone receptor status and disease stage

* however even patients with similar prognostic features can experience different clinical outcomes after treatment . Despite significant advancements in early screening and diagnostic techniques, the incidence of breast cancer continues to rise annually, accounting for approximately 11.7% of all newly diagnosed cancer cases. So detection of new prognostic indicators is critical for selecting the optimal treatment modalities, evaluating the response and creating a follow-up plan to improve clinical outcome . Phosphatidylinositol glycan anchor biosynthesis class U (PIGU), also known as cell division cycle 91-like 1 (CDC91L1), is an important subunit of glycosylphosphatidylinositol transaminase (GPI-T) complex. It has been reported that the over-activity of certain components of the GPI T complex contributes to the development of various cancers, such as

breast cancer, bladder cancer, lymphoma, and non-small cell lung cancer. Studies have shown that PIGU has the potential to be a prognostic biomarker and therapeutic target for liver cancer, ovarian cancer and colorectal cancer . Also, PIGU expression levels have been associated with radiotherapy for differentiated thyroid cancer and the risk of cutaneous melanoma. It has been demonstrated that PIGU promotes hepatocellular carcinoma (HCC) progression via increasing HCC cell viability, migration, invasion and inhibiting apoptosis by activating the transcription factor nuclear factor-kappa B (NF-κB) pathway . Recent researches verify that PIGU protein levels were significantly higher in breast cancer patients compared to normal people

. So it was speculated that PIGU is playing an important role in tumor development, progression and it can be considered as a marker for breast cancer screening and prognosis (12).

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• The study will be carried on female patients who diagnosed as breast cancer based on pathological and radiological confirmation, recruited from Clinical Oncology Departments and outpatient clinics, SECI, Assiut University

Exclusion Criteria

• Patients diagnosed with other concomitant cancer.
• Patients who have already received chemotherapy or radiotherapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of the serum level of PIGU protein in patients with breast cancer	baseline	Evaluate the relation between serum level of PIGU protein in breast cancer patients and other clinical, laboratory and pathological data of the patients.