Study of Molecular Characterisation of Early Operable Pri... | NCT06830590

Studies
Study of Molecular Characterisation of Early Operable Primary Breast Cancer in Pakistani Population

NCT06830590

Sponsor

Liaquat University of Medical & Health Sciences

Status

Recruiting

Last Update Posted

Aug 13, 2025Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Breast Cancer
Molecular Pathway Deregulation
Treatment

Interventions

Molecular characterisation

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2016Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Feb 11, 2025

First Submission Date that Met QC Criteria

Feb 11, 2025

First Posted Date

Feb 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2025

Last Update Posted Date

Aug 13, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Binafsha Manzoor Syed, Prof. Dr., Liaquat University of Medical & Health SciencesPrincipal Investigator

Lead Sponsor

Liaquat University of Medical & Health SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early operable primary breast cancer		women any age group confirmed diagnosis of breast cancer	Procedure: Molecular characterisation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Molecular characterisation	Procedure	All patients treated by surgery were included without any neoadjuvant therapy	Early operable primary breast cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Breast cancer specific survival in correlation with molecular pattern		10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

patients received pre-operative chemotherapy or radiotherapy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Females only

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Binafsha Manzoor M Syed, MBBS, PhD	Contact	+923332749201		Binafsha.syed@lumhs.edu.pk

Overall Officials

Name	Affiliation	Role
Binafsha Manzoor M Syed, MBBS, PhD	Liaquat University of Medical & Health Sciences, Jamshoro	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Binafsha M Syed	Recruiting	Jamshoro			Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided