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

Sponsor
National Guard Health Affairs (Other)
Overall Status
Suspended
CT.gov ID
NCT01320488
Collaborator
(none)
600
Enrollment
1
Location
82
Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Breast Cancer in Young Women: Is it Different?
    Study Start Date :
    Oct 1, 2009
    Anticipated Primary Completion Date :
    Aug 1, 2016
    Anticipated Study Completion Date :
    Aug 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Guard Health Affairs
    ClinicalTrials.gov Identifier:
    NCT01320488
    Other Study ID Numbers:
    • RC08/117
    First Posted:
    Mar 22, 2011
    Last Update Posted:
    May 13, 2016
    Last Verified:
    May 1, 2016
    Keywords provided by National Guard Health Affairs
    Breast Cancer
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of May 13, 2016