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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00959244
First received: August 13, 2009
Last updated: June 10, 2010
Last verified: June 2010

August 13, 2009
June 10, 2010
February 2009
September 2009   (final data collection date for primary outcome measure)
Estrogen compounds in urine [ Time Frame: at baseline at 6 months and annually ] [ Designated as safety issue: No ]
Estrogen compounds in urine [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00959244 on ClinicalTrials.gov Archive Site
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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)

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:

  • 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Urine

Non-Probability Sample

Women with breast cancer.

Breast Cancer
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2009
September 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Newly diagnosed ductal carcinoma in situ or invasive 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

    • Urine specimens were collected at baseline, 6 months, and then annually
  • Estrogen receptor or progesterone receptor positive

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • ECOG performance status 0-2
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent use of estrogen(s)
Female
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00959244
502-08, P30CA036727, UNMC-50208
No
Ercole Cavalieri, Ph.D., UNMC Eppley Cancer Center at the University of Nebraska Medical Center
University of Nebraska
National Cancer Institute (NCI)
Principal Investigator: Ercole Cavalieri, DSc University of Nebraska
University of Nebraska
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP