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

University of Nebraska

Status: Completed

Conditions: Breast Cancer

Treatments: Other: laboratory biomarker analysis; Other: mass spectrometry; Other: medical chart review; Other: high performance liquid chromatography

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00959244

P30CA036727 (U.S. NIH Grant/Contract)

0502-08-EP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

  o Urine specimens were collected at baseline, 6 months, and then annually

• Estrogen receptor or progesterone receptor positive

• ECOG performance status 0-2

Exclusion criteria

• Not pregnant or nursing
• No concurrent use of estrogen(s)