NCT02781116

Brief Summary

This study will have great impact and influence in the medical setting as the targeted model that will be derived from this study will be the pioneer in our region. This model will be beneficial in identifying risk factors and its association with the Arab women population. Furthermore, it will bring chemotherapy prevention once the risk factors and the model are established. Risk factors maybe different from those identified in western women by Gail and IBIS Models

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

3.1 years

First QC Date

March 31, 2016

Last Update Submit

May 19, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • The number of new breast cancer identified with the new risk assessment model that more applicable for our population

    5 years

Secondary Outcomes (3)

  • 1. The number of new breast cancer cases using Tyrer Cuzick models that applied in our patients

    5 years

  • Collect number of IVF and ovarian stimulation in prediction of breast cancer

    5 years

  • Collect BMI measure in kg/m^2

    5 years

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All female patients attended the breast cancer screening center

You may qualify if:

  • All female patients attended the breast cancer screening center

You may not qualify if:

  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdul Aziz Medical City for National Guard Health Affairs

Riyadh, 11426, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Omalkhair Abulkhair

    Ministry of National Guard Health Affairs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Omalkhair Abulkhair

CONTACT

AbulkhairO@NGHA.MED.SA

Nagham Sheblaq

CONTACT

oncologyresearch@ngha.med.sa

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Supervisor

Study Record Dates

First Submitted

March 31, 2016

First Posted

May 24, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations

SA(1)