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Tracking Information | |||||
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First Received Date ICMJE | May 3, 2007 | ||||
Last Updated Date | May 9, 2009 | ||||
Start Date ICMJE | April 2007 | ||||
Current Primary Outcome Measures ICMJE |
Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density | ||||
Original Primary Outcome Measures ICMJE |
Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density | ||||
Change History | Complete list of historical versions of study NCT00470561 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Descriptive Information | |||||
Brief Title ICMJE | Effect of Aspirin on Mammogram Density in Healthy Postmenopausal Women With a Moderate or High Level of Breast Density | ||||
Official Title ICMJE | The Effect of Aspirin on Mammogram Density (TEAM) | ||||
Brief Summary | RATIONALE: Aspirin may be effective in reducing breast density in healthy postmenopausal women with a moderate or high level of breast density. PURPOSE: This randomized clinical trial is studying the effect of aspirin on mammogram density compared with a placebo in healthy postmenopausal women with a moderate or high level of breast density. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Participants are randomized to 1 of 2 treatment arms.
Blood and urine samples are collected at baseline and at 6 months. Single-nucleotide polymorphisms in the UGT genes and variable number of tandem repeat-type polymorphisms are genotyped. PROJECTED ACCRUAL: A total of 144 participants will be accrued for this study. |
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Study Phase | |||||
Study Type ICMJE | Observational | ||||
Study Design ICMJE | |||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 144 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Female | ||||
Ages | 55 Years to 75 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00470561 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | CDR0000544639, FHCRC-PHS-1908.00, FHCRC-1908 | ||||
Study Sponsor ICMJE | Fred Hutchinson Cancer Research Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | June 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |