ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01320488
Recruitment Status : Suspended (Difficulty in enrolling patients)
First Posted : March 22, 2011
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Female Breast Cancer

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 Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Cancer in Young Women: Is it Different?
Study Start Date : October 2009
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. experience of breast cancer in young women [ Time Frame: 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.


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320488


Locations
Saudi Arabia
King Abdul Aziz Medical City for National Guard Health Affairs
Riyadh, Saudi Arabia, 11426
Sponsors and Collaborators
National Guard Health Affairs
Investigators
Principal Investigator: Omalkahir Abulkhair, MD King Abdul Aziz Medical City for National Guard

Responsible Party: National Guard Health Affairs
ClinicalTrials.gov Identifier: NCT01320488     History of Changes
Other Study ID Numbers: RC08/117
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by National Guard Health Affairs:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases