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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Brystkreft

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

316

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Minnesota
  - Rochester, Minnesota, Forente stater, 55905
    - Mayo Clinic Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Potensielle

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mayo Clinic

Etterforskere

Hovedetterforsker: Sandhya Pruthi, MD, Mayo Clinic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. mai 2005

Primær fullføring (Faktiske)

17. juni 2010

Studiet fullført (Faktiske)

30. juni 2015

Datoer for studieregistrering

Først innsendt

9. mai 2009

Først innsendt som oppfylte QC-kriteriene