Study of Urine Samples From Women With Newly Diagnosed Breast Cancer Enrolled on Clinical Trial UNMC-08105
|ClinicalTrials.gov Identifier: NCT00959244|
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : June 11, 2010
RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at urine samples from women with newly diagnosed breast cancer.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: mass spectrometry Other: medical chart review|
- To learn the effects of selected agents (tamoxifen and aromatase inhibitors) on the profile of estrogen metabolites, glutathione conjugates, and depurinating DNA adducts in urine from women with breast cancer.
OUTLINE: Previously collected urine samples are analyzed for 40 estrogen metabolites, conjugates, and depurinating DNA adducts by ultra-performance liquid chromatography with tandem mass spectrometric detection.
Patient information (e.g., race, body mass index, age at menarche, menopausal status, age at menopause if applicable, smoking history, alcohol consumption) is collected through medical record review.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||1) Effects of Therapeutic Agents on Estrogens in the Breast 2) Utilizing the Resources of the Breast Cancer Collaborative Registry (BCCR)|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Other: high performance liquid chromatography
- Estrogen compounds in urine [ Time Frame: at baseline at 6 months and annually ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959244
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-6805|
|Principal Investigator:||Ercole Cavalieri, DSc||University of Nebraska|