Breast Cancer in Young Women: Is it Different? (YoungWomen)

This study is currently recruiting participants.
Verified January 2014 by National Guard Health Affairs
Sponsor:
Information provided by (Responsible Party):
National Guard Health Affairs
ClinicalTrials.gov Identifier:
NCT01320488
First received: March 19, 2011
Last updated: January 15, 2014
Last verified: January 2014

March 19, 2011
January 15, 2014
October 2009
December 2014   (final data collection date for primary outcome measure)
experience of breast cancer in young women [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01320488 on ClinicalTrials.gov Archive Site
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Breast Cancer in Young Women: Is it Different?
Breast Cancer in Young Women: Is it Different?

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

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.

Female Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
October 2019
December 2014   (final data collection date for primary outcome measure)

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
Female
40 Years and older
No
Contact: Omalkhair Abulkhair, MD 0096612520088 ext 141077 abulkhairo@ngha.med.sa
Contact: Oncology Research 0096612520088 ext 14601 oncologyresearch@ngha.med.sa
Saudi Arabia
 
NCT01320488
RC08/117
No
National Guard Health Affairs
National Guard Health Affairs
Not Provided
Principal Investigator: Omalkahir Abulkhair, MD King Abdul Aziz Medical City for National Guard
National Guard Health Affairs
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP