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

This study has suspended participant recruitment.
(Difficulty in enrolling patients)
Sponsor:
Information provided by (Responsible Party):
National Guard Health Affairs
ClinicalTrials.gov Identifier:
NCT01320488
First received: March 19, 2011
Last updated: May 12, 2016
Last verified: May 2016
  Purpose
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
Female Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Cancer in Young Women: Is it Different?

Resource links provided by NLM:


Further study details as provided by National Guard Health Affairs:

Primary Outcome Measures:
  • 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.


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

Estimated Enrollment: 600
Study Start Date: October 2009
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: National Guard Health Affairs
ClinicalTrials.gov Identifier: NCT01320488     History of Changes
Other Study ID Numbers: RC08/117 
Study First Received: March 19, 2011
Last Updated: May 12, 2016
Health Authority: Saudi Arabia: Ethics Committee

Keywords provided by National Guard Health Affairs:
Breast Cancer

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

ClinicalTrials.gov processed this record on August 28, 2016