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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00959244
• Lead Sponsor: University of Nebraska

Brief 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.

Study Timeline

• Study Start: 2009-02-02
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Primary Completion: 2009-09-25
• Study Completion: 2009-09-25
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estrogen compounds	at baseline at 6 months and annually	Estrogen compounds in urine

Trial Locations

Locations (1)

Eppley Cancer Center, University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States