Breast Cancer in Young Women: Is it Different?

Suspended

• Conditions: Female Breast Cancer

• Registration Number: NCT01320488
• Lead Sponsor: National Guard Health Affairs

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

Detailed Description

The study 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 at least 400 of these women will agree to participate in the study. The comparable control group of older patients with breast cancer will be used for study comparison. Patient surveys, medical record review, and blood and tissue collection will be utilized. Women will be surveyed every 6 months after diagnosis. The study will investigate short and long-term disease and treatment issues, and psychosocial concerns. We will also collect tumor and blood samples to characterize the pathological and molecular aspects of tumors, and establish tumor bank for future studies.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-03-19
• Study First Submitted QC: 2011-03-19
• Study First Posted: 2011-03-22
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• 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

Exclusion Criteria

• Absence of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
experience of breast cancer in young women	10 years	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.

Trial Locations

Locations (1)

King Abdul Aziz Medical City for National Guard Health Affairs; 🇸🇦 Riyadh, Saudi Arabia