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

NCT00959244 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-09-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • University of Nebraska

    lead OTHER

Principal Investigators

  • Ercole Cavalieri, DSc · Eppley Cancer Center, University of Nebraska Medical Center

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-02
Primary Completion
2009-09-25
Completion
2009-09-25

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00959244 on ClinicalTrials.gov