Phosphatidylinositol Glycan Anchor Biosynthesis Class U Protein in Breast Cancer

NCT ID: NCT07130162

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-10-31

Brief Summary

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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

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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).

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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breast cancer patients

48 case

Measurement of serum PIGU protein concentrations of patients and controls by Enzyme-Linked Immunosorbent Assay (ELISA)

Intervention Type DIAGNOSTIC_TEST

Measurement of serum PIGU protein concentrations of patients and controls by Enzyme-Linked Immunosorbent Assay (ELISA)

healthy controls

48 case

Measurement of serum PIGU protein concentrations of patients and controls by Enzyme-Linked Immunosorbent Assay (ELISA)

Intervention Type DIAGNOSTIC_TEST

Measurement of serum PIGU protein concentrations of patients and controls by Enzyme-Linked Immunosorbent Assay (ELISA)

Interventions

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Measurement of serum PIGU protein concentrations of patients and controls by Enzyme-Linked Immunosorbent Assay (ELISA)

Measurement of serum PIGU protein concentrations of patients and controls by Enzyme-Linked Immunosorbent Assay (ELISA)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Esraa Gamal Neyaz Mohamed

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Esraa gamal neyaz, Resident doctor

Role: CONTACT

+20-01020731418

Noha Gaber Sayed, Prof. Dr

Role: CONTACT

+20-01003305354

References

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An S, Liu F, Shi Y. Identification of serum phosphatidylinositol glycan anchor biosynthesis class U protein as diagnostic biomarker for breast cancer. Clin Chim Acta. 2025 Mar 1;569:120183. doi: 10.1016/j.cca.2025.120183. Epub 2025 Feb 6.

Reference Type BACKGROUND
PMID: 39922250 (View on PubMed)

Giaquinto AN, Sung H, Newman LA, Freedman RA, Smith RA, Star J, Jemal A, Siegel RL. Breast cancer statistics 2024. CA Cancer J Clin. 2024 Nov-Dec;74(6):477-495. doi: 10.3322/caac.21863. Epub 2024 Oct 1.

Reference Type BACKGROUND
PMID: 39352042 (View on PubMed)

Azim HA, Elghazawy H, Ghazy RM, Abdelaziz AH, Abdelsalam M, Elzorkany A, Kassem L. Clinicopathologic Features of Breast Cancer in Egypt-Contemporary Profile and Future Needs: A Systematic Review and Meta-Analysis. JCO Glob Oncol. 2023 Mar;9:e2200387. doi: 10.1200/GO.22.00387.

Reference Type BACKGROUND
PMID: 36888929 (View on PubMed)

Thakur N, Singh R, Sunigdha, Devgan R, Sharma A. Clinicopathological prognostic factors for survival in patients with breast cancer: a retrospective study from a tertiary cancer centre from North-West India. Ecancermedicalscience. 2025 Mar 6;19:1865. doi: 10.3332/ecancer.2025.1865. eCollection 2025.

Reference Type BACKGROUND
PMID: 40492224 (View on PubMed)

Wei X, Yang W, Zhang F, Cheng F, Rao J, Lu L. PIGU promotes hepatocellular carcinoma progression through activating NF-kappaB pathway and increasing immune escape. Life Sci. 2020 Nov 1;260:118476. doi: 10.1016/j.lfs.2020.118476. Epub 2020 Sep 21.

Reference Type BACKGROUND
PMID: 32971102 (View on PubMed)

Other Identifiers

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PIGU in breast cancer

Identifier Type: -

Identifier Source: org_study_id

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