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


N/A
19 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome 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

Safety Issue:

No

Principal Investigator

Sandhya Pruthi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000582153

NCT ID:

NCT00897208

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • ductal breast carcinoma in situ
  • breast cancer in situ
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating

Name

Location
Mayo Clinic Cancer Center Rochester, Minnesota  55905