Knowledge and Perception of Clinical Trial Participation... | NCT04569955

Studies
Knowledge and Perception of Clinical Trial Participation in Breast Cancer Patients in Egypt

NCT04569955

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Sep 30, 2020Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Breast Cancer
Clinical Trials

Interventions

Knowledge and perception of clinical trial participation

Countries

Egypt

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2020Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jul 7, 2020

First Submission Date that Met QC Criteria

Sep 28, 2020

First Posted Date

Sep 30, 2020Actual

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

Sep 28, 2020

Last Update Posted Date

Sep 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hagar Elghazawy, Lecturer of clinical oncology, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Clinical trials are essential to translate new therapy concepts or rather any intervention into the medical routine. Beside the well designed trial protocol, the success of clinical trials depends on patient recruitment and participation.
This study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in Breast cancer female patients in Egypt, as an example to Low/Middle income countries.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Knowledge and perception of clinical trial participation	Behavioral	This study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in Breast cancer female patients in Egypt, as an example to Low/Middle income countries

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of breast cancer patients who accept to participate in clinical trials		1 year

Secondary Outcomes

Measure	Description	Time Frame
The barriers for participation in clinical trials		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female breast cancer patients

Exclusion Criteria:

Patients who refuse participation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

-Egyptian female Breast cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hagar Elghazawy, MD	Contact	01006232406		dr.hagar.elghazawy@med.asu.edu.eg

Overall Officials

Name	Affiliation	Role
Hagar Elghazawy	Ain shams university, faculty of medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams university, faculty of medicine	Recruiting	Cairo	Select	1667	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

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