NCT07130162

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Sep 2025Oct 2026

First Submitted

Initial submission to the registry

August 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 12, 2025

Last Update Submit

August 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Detection of the serum level of PIGU protein in patients with breast cancer

    Evaluate the relation between serum level of PIGU protein in breast cancer patients and other clinical, laboratory and pathological data of the patients.

    baseline

Study Arms (2)

breast cancer patients

48 case

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

healthy controls

48 case

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

Interventions

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

breast cancer patientshealthy controls

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

female patients who diagnosed as breast cancer based on pathological and radiological confirmation

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 39922250BACKGROUND
  • 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.

    PMID: 39352042BACKGROUND
  • 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.

    PMID: 36888929BACKGROUND
  • 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.

    PMID: 40492224BACKGROUND
  • 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.

    PMID: 32971102BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Esraa gamal neyaz, Resident doctor

CONTACT

Noha Gaber Sayed, Prof. Dr

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 19, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08