NCT06830590

Brief Summary

This study is looking at the biological characteristics of early operable primary breast cancer in Pakistani Population by using IHC

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

9.9 years

First QC Date

February 11, 2025

Last Update Submit

August 7, 2025

Conditions

Breast CancerMolecular Pathway DeregulationTreatment

Keywords

Breast cancerMolecular characterisation

Outcome Measures

Primary Outcomes (1)

  • Breast cancer specific survival in correlation with molecular pattern

    10 years

Study Arms (1)

Early operable primary breast cancer

1. women 2. any age group 3. confirmed diagnosis of breast cancer

Procedure: Molecular characterisation

Interventions

Molecular characterisationPROCEDURE

All patients treated by surgery were included without any neoadjuvant therapy

Early operable primary breast cancer

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population are women with early operable primary breast cancer underwent surgery without any prior treatment.

You may qualify if:

  • Women with confirmed diagnosis of breast cancer without history of taking neoadjuvant therapy Good quality tumour samples available for IHC

You may not qualify if:

  • patients received pre-operative chemotherapy or radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binafsha M Syed

Jamshoro, Pakistan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

FFPE blocks of breast tumors will be retained

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Binafsha Manzoor M Syed, MBBS, PhD

    Liaquat University of Medical & Health Sciences, Jamshoro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Binafsha Manzoor M Syed, MBBS, PhD

CONTACT

+923332749201Binafsha.syed@lumhs.edu.pk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

February 1, 2016

Primary Completion

December 30, 2025

Study Completion

December 31, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

data will be shared in the form of overall results with pattern of biomarkers. Individual participants data will not be shared

Locations

PA(1)