Trial record 6 of 2627 for:    breast neoplasms AND (woman OR women OR female)

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00897208
First received: May 9, 2009
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Other: high performance liquid chromatography
Other: laboratory biomarker analysis
Other: mass spectrometry
Other: medical chart review
Procedure: evaluation of cancer risk factors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estrogen-DNA Adducts in Breast, Urine and Serum as Biomarkers of Breast Cancer Risk

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2005
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The target population is adult women, ages 19 to 80 years of age. In 2003, there were approximately 2000 new and 3000 established patient visits in the Breast Diagnostic Clinic (BDC) and Breast Cancer Clinic (BCC) Our new patients include those seen in the BDC with new breast concerns and those at seeking counseling regarding a family history or at high risk for developing breast cancer, as well as those women seen in the BCC with a new diagnosis of invasive or non-invasive breast cancer.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897208

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Sandhya Pruthi, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00897208     History of Changes
Other Study ID Numbers: 19-2005, 19-2005, 06-008665
Study First Received: May 9, 2009
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
breast cancer
ductal breast carcinoma in situ
breast cancer in situ
stage IA breast cancer
stage IB breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Skin Diseases
Carcinoma
Adenocarcinoma

ClinicalTrials.gov processed this record on April 16, 2014