An observational study in Breast Cancer, sponsored by University of Nebraska. Completed at 1 site in United States. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by University of Nebraska · Observational
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.
OBJECTIVES:
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 100 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women with breast cancer
Urine biospecimens available from participation in protocol UNMC-08105 (IRB#311-06), the Breast Cancer Collaborative Registry (BCCR), which included treatment with tamoxifen or an aromatase inhibitor
o Urine specimens were collected at baseline, 6 months, and then annually
Exclusion Criteria:
Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.
The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.
Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.
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.
Estrogen compounds
Estrogen compounds in urine
Time frame: at baseline at 6 months and annually
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University of Nebraska