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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

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ClinicalTrials.gov Identifier: NCT00897208
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Brief 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.


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

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.


Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estrogen-DNA Adducts in Breast, Urine and Serum as Biomarkers of Breast Cancer Risk
Actual Study Start Date : May 2005
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00897208     History of Changes
Other Study ID Numbers: 19-2005
19-2005 ( Other Identifier: Mayo Clinic Cancer Center )
06-008665 ( Other Identifier: Mayo Clinic IRB )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

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
Carcinoma in Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type