Breast Cancer in Young Women: Is it Different?

Female Breast Cancer Clinical Trial

— YoungWomen  

Official title:

Breast Cancer in Young Women: Is it Different?

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01320488
• Other study ID #: RC08/117
• Status: Suspended
• Phase: N/A
• First received: March 19, 2011
• Last updated: May 12, 2016
• Start date: October 2009
• Est. completion date: August 2016

Study information

• Verified date: May 2016
• Source: National Guard Health Affairs
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 600
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Female Breast Cancer

Locations

Country	Name	City	State
Saudi Arabia	King Abdul Aziz Medical City for National Guard Health Affairs	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
National Guard Health Affairs

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes