NCT01320488

Brief Summary

Breast cancer is the leading cancer among women in Saudi Arabia representing almost the third of cancer diagnosed in Saudi women. Breast cancer in Saudi women is more frequently observed at young age. The data on this observation is either lacking or scares. Furthermore, the pathological and molecular features of breast cancer in young women are not clear. The study will provide important information to the national health care planner about this disease in young women including shedding light on possible genetic risk factors

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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

October 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

6.8 years

First QC Date

March 19, 2011

Last Update Submit

May 12, 2016

Conditions

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • experience of breast cancer in young women

    To identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer in King Abdulaziz Medical City and other collaborating hospitals to assess a broad range of variables at baseline and over the course.

    10 years

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The proposed project is a prospective longitudinal cohort study of young women with breast cancer. Over a 3-year period, we aim to identify a total of 600 women with newly diagnosed breast cancer, of those 300 women age 40 and younger and 300 older women from academic and community health care institutions across the Riyadh area. It is anticipated that at least 400 of these women (from study and control group) will agree to participate in the study.

You may qualify if:

  • Female
  • Diagnosis of breast cancer
  • Age 40 or younger at diagnosis for study group and older women for control group
  • Informed consent obtained from patient

You may not qualify if:

  • Absence of informed consent

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

tumor and blood specimens to characterize the pathology and biology of the tumors, and establish tumor bank for future studies

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Omalkahir Abulkhair, MD

    King Abdul Aziz Medical City for National Guard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2011

First Posted

March 22, 2011

Study Start

October 1, 2009

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations