Studying Biomarkers in Nipple Fluid, Urine, and Blood Samples From Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer and in Women at Risk of Developing Breast Cancer

Breast Cancer Clinical Trial

Official title:

Estrogen-DNA Adducts in Breast, Urine and Serum as Biomarkers of Breast Cancer Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897208
• Other study ID #: 19-2005
• Secondary ID: 19-200506-008665
• Status: Completed
• Start date: May 20, 2005
• Est. completion date: June 30, 2015

Study information

• Verified date: October 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of nipple fluid, urine, and blood in the laboratory from patients with cancer and from patients at risk of developing cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors learn more about breast cancer and identify patients at risk of developing breast cancer.

PURPOSE: This laboratory study is looking at biomarkers in nipple fluid, urine, and blood samples from women with newly diagnosed ductal carcinoma in situ or stage I or stage II breast cancer and in women at risk of developing breast cancer.

Description:

OBJECTIVES:

• To determine the levels of catechol estrogens (CE), CE metabolites, CE-DNA adducts, and CE conjugates in nipple aspirate fluid samples obtained from women with newly diagnosed ductal carcinoma in situ or stage I or II breast cancer and from women at high risk of developing breast cancer.

OUTLINE: Patients with newly diagnosed breast cancer or at high risk of developing breast cancer undergo nipple aspiration. The nipple aspirate fluid is obtained from the unaffected breast and is analyzed for 31 estrogen metabolites, conjugates, and depurinating DNA adducts by high-performance liquid chromatography (LC) with electrochemical and mass spectrometric detectors. All patients undergo urine and serum sample collection. The urine samples are analyzed by ultraperformance LC monitored by tandem mass spectrometry for estrogen metabolites, conjugates, and depurinating DNA adducts.

Patients' charts are reviewed to obtain information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, and HER2/neu status (for patients with newly diagnosed breast cancer), menopausal status, reproductive history, history of breast disease, medication use, smoking history, and history of alcohol consumption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: June 30, 2015
• Est. primary completion date: June 17, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 80 Years

Eligibility

DISEASE CHARACTERISTICS:

• Meets 1 of the following criteria:

• Newly diagnosed (within 30 calendar days of diagnosis) stage I or II breast cancer

• Node-negative or node-positive disease

• Newly diagnosed ductal carcinoma in situ (stage 0) of the breast

• At high risk of developing breast cancer, as indicated by at least 1 of the following criteria:

• Gail model 5-year risk score = 1.66%

• Gail model lifetime-risk estimate = 20%

• Known deleterious BRCA 1 or 2 gene mutation carrier

• History of lobular carcinoma in situ or atypical ductal or lobular hyperplasia

• At low or average risk of developing breast cancer (control group)

• Gail model 5-year risk score < 1.66% or lifetime risk < 20%

• No advanced breast cancer

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Pre- or post-menopausal

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for breast cancer or any other cancer

• More than 3 months since prior and no concurrent estrogen or other hormones

• More than 3 months since prior oral contraceptives

• No concurrent selective estrogen receptor modulators (tamoxifen citrate or raloxifene)

• No concurrent aromatase inhibitors

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma in Situ

Intervention

Other:
• high performance liquid chromatography

• laboratory biomarker analysis

• mass spectrometry

• medical chart review

Procedure:
• evaluation of cancer risk factors

Locations

Country	Name	City	State
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the levels of estrogens, catechol estrogen (CE) metabolites, CE-glutathione conjugates, and CE-DNA adducts (N3Ade and N7Gua) among healthy women, high-risk women, and women with breast cancer