NCT00959244

Study of Urine Samples From Women With Newly Diagnosed Breast Cancer Enrolled on Clinical Trial UNMC-08105

1) Effects of Therapeutic Agents on Estrogens in the Breast 2) Utilizing the Resources of the Breast Cancer Collaborative Registry (BCCR)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Nebraska · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	high performance liquid chromatography	Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.
OTHER	laboratory biomarker analysis	The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.
OTHER	mass spectrometry	Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.
OTHER	medical chart review	Information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, menopausal status and breast disease, body mass index, age at menarche, menopausal status (pre- or peri- menopausal or postmenopausal), age at menopause if applicable, chemotherapy regimen (if applicable), radiation therapy (if applicable), smoking history, alcohol consumption, pregnancy history including age at each pregnancy, lactation, history of benign breast disease, hysterectomy and disease type.

Timeline

• Start date: 2009-02-02
• Primary completion: 2009-09-25
• Completion: 2009-09-25
• First posted: 2009-08-14
• Last updated: 2023-09-01

Locations

1 site across 1 country: United States