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

This study is ongoing, but not recruiting participants.

First Received: August 13, 2009 Last Updated: October 6, 2009 History of Changes

Sponsor:	University of Nebraska
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00959244

Purpose

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.

Condition	Intervention
Breast Cancer	Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: mass spectrometry Other: medical chart review

Study Type:	Observational
Official Title:	1) Effects of Therapeutic Agents on Estrogens in the Breast 2) Utilizing the Resources of the Breast Cancer Collaborative Registry (BCCR)

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Urine and Urination

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Estrogen compounds in urine [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2009

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959244

Locations

United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805

Sponsors and Collaborators

University of Nebraska

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Ercole Cavalieri, DSc

University of Nebraska

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000634796, UNMC-50208
Study First Received:	August 13, 2009
Last Updated:	October 6, 2009
ClinicalTrials.gov Identifier:	NCT00959244 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

ductal breast carcinoma in situ
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 09, 2010