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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

4. oktober 2018 opdateret af: Mayo Clinic

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Brystkræft

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

316

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Minnesota
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: Kohorte
Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mayo Clinic

Efterforskere

Ledende efterforsker: Sandhya Pruthi, MD, Mayo Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. maj 2005

Primær færdiggørelse (Faktiske)

17. juni 2010

Studieafslutning (Faktiske)

30. juni 2015

Datoer for studieregistrering

Først indsendt

9. maj 2009

Først indsendt, der opfyldte QC-kriterier