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Study Summary
No. 2004-0772:.......Breast......Richard L. Theriault......Breast Medical Oncology
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Study Summary Title
Study Summary
Number:		2004-0772
Study Title:NCCN Breast Cancer Outcomes Project Database at MDACC
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Physician New Patient Referral
Name:Richard L. TheriaultPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Breast Medical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-0758
Contact us about clinical trials
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General Information
Disease Group:BreastSupported By:N/A
Phase of Study:N/AReturn
Visit:		N/A.
Treatment
Agents:		NoneHome Care:None. Not a therapy trial.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		N/A.
Description/
Intervention:		This clinical research project is designed to collect treatment and outcomes
data on all newly diagnosed patients with breast cancer for entry into a
multi-institutional database. The information will be used to monitor breast
cancer treatment practice at each center participating in the project and
compare the results to national norms. In addition, data from the project will
be used to evaluate breast cancer treatment in accordance with recognized
national breast cancer treatment guidelines. Annual analyses of results from
the database project will be used to update the breast cancer practice
guidelines.
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Study Objectives / Outcomes
  • To collect treatment and outcomes data on all newly diagnosed breast cancer patients at NCCN participating institutions for entry into a multi-institutional database. All data are collected retrospectively.
  • To promote routine monitoring of breast cancer treatment practice at each center and compare results to national norms.
  • To promote evaluation of breast cancer treatment guideline concordance.
  • To use results of analyses as an input into the annual updating of practice guidelines.
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    Study Status Information
    Study Activation / Registration Date:
    IRB Review and Approval Date:02/08/2005
    Study Type:Other
    Recruitment Status:Open
    Projected Accrual:20,000+
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) Newly diagnosed female breast cancer patients who are at least 18 years of age.

    2) Breast cancer histology consistent with at least one of the following American Joint Committee on Cancer (AJCC) defined types: - Carcinoma, NOS (not otherwise specificed) - Ductal (intraductal (in situ), Invasive with predominant intraductal component, Invasive, NOS, Comedo, Inflammatory, Medllary, Mucinous (colloid), Papillary, Scirrhous, Tubular, Other) - Lobular (in situ, Invasive with predominent in situ component, invasive) - Nipple (Paget's disease, NOS, Paget's disease with intraductal carcinoma, Paget's disease with invasive carcinoma) - Other (undifferentiated carcinoma)

    3) Patients receiving other or all primary breast cancer treatment (e.g., cancer-directed surgery, chemotherapy or hormonal therapy ) in the NCCN institution on or after July 1, 1997.

    4) Patients with a previous history of breast cancer without any distant metastases if they meet the previous criteria.

    5) Patients with a history of any other type of cancer but without a history of distant metastases or evidence of relapse if they meet the previous criteria.
    Exclusion Criteria:1) Patients who present to the NCCN institution with or are diagnosed with cancer recurrence, breast cancer type sarcoma or having simultaneous cancers.

    2) Patients receiving all primary breast cancer treatment (e.g., cancer-directed surgery, chemotherapy, and hormonal therapy) outside a participating institution.

    3) Patients presenting to the participating institution only for bone marrow transplantation or radiation therapy.

    4) Males will be excluded from our data collection because the published NCCN Guidelines are directed towards female breast cancer only.
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    Links
    Registration Number: Not Applicable Clinical Trial
    Other Links:
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    Results

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