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

Breast Cancer Clinical Trial

Official title:

1) Effects of Therapeutic Agents on Estrogens in the Breast 2) Utilizing the Resources of the Breast Cancer Collaborative Registry (BCCR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959244
• Other study ID #: 0502-08-EP
• Secondary ID: P30CA036727
• Status: Completed
• Start date: February 2, 2009
• Est. completion date: September 25, 2009

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 25, 2009
• Est. primary completion date: September 25, 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• high performance liquid chromatography
Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.
• laboratory biomarker analysis
The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.
• mass spectrometry
Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.
• 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.

Locations

Country	Name	City	State
United States	Eppley Cancer Center, University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estrogen compounds	Estrogen compounds in urine	at baseline at 6 months and annually