NCT07056205

Brief Summary

Expression of ER, PR and HER2/neu in initial and recurrent breast cancer and correlate the results to different clinical and pathological parameters as patient age,sex, tumor location, status of nodal involvement and lymphovascular invasion

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Start

First participant enrolled

January 1, 2021

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 9, 2025

Status Verified

May 1, 2025

Enrollment Period

4.8 years

First QC Date

June 29, 2025

Last Update Submit

June 29, 2025

Conditions

Keywords

ER,PR,HER2/neu,breast cancer

Outcome Measures

Primary Outcomes (1)

  • Comparison between initial and recurrent breast cancer in immunohistochemical expression of ER,PR and HER2/neu

    6 months

Secondary Outcomes (1)

  • Correlate the results of immunohistochemical expression of ER,PRand HER2/neu with the patients age ,sex,nodal status and lymphovascular invasion

    6 months

Study Arms (1)

archived histological slides and immune-stained slides of 100 patient with breast cancer

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Details\- Inclusion criteria: Patients with excised breast cancer then experienced recurrence at same site. Patients with evaluated ER, PR and HER2/neu for both initial and recurrent tumors. \- Exclusion criteria: Cases with insufficient clinical of pathological data. Deficient ER, PR and HER2/neu status in either initial or recurrent tumor
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

archived histological slides and immune-stained slides of100 patient with initial and recurrent mammary carcinoma will be obtained from Pathology Laboratory at Sohag Oncology Center.

You may qualify if:

  • Patients with excised breast cancer then experienced recurrence at same site. Patients with evaluated ER, PR and HER2/neu for both initial and recurrent tumors.

You may not qualify if:

  • Cases with insufficient clinical of pathological data. Deficient ER, PR and HER2/neu status in either initial or recurrent tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Sohag, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Archived histological slides and immune-stained slides of 100 patient with initial and recurrent mammary carcinoma will be obtained from Pathology Laboratory at Sohag Oncology Center.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comparative expression of ER, PR and HER2/neu in initial and recurrent breast cancer.

Study Record Dates

First Submitted

June 29, 2025

First Posted

July 9, 2025

Study Start

January 1, 2021

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

July 9, 2025

Record last verified: 2025-05

Locations