Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments high performance liquid chromatography, laboratory biomarker analysis, mass spectrometry, medical chart review, evaluation of cancer risk factors
Sponsor Mayo Clinic
Start date May 2005
End date September 2016
Trial size 300 participants
Trial identifier NCT00897208, 06-008665, 19-2005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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
time frame:

Eligibility Criteria

Female participants from 19 years up to 80 years old.

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

Additional Information

Official title Estrogen-DNA Adducts in Breast, Urine and Serum as Biomarkers of Breast Cancer Risk
Principal investigator Sandhya Pruthi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.