NCT00897208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2005

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2010

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

5.1 years

First QC Date

May 9, 2009

Last Update Submit

October 4, 2018

Conditions

Breast Cancer

Keywords

breast cancerductal breast carcinoma in situbreast cancer in situstage IA breast cancerstage IB breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (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

Interventions

high performance liquid chromatographyOTHER
laboratory biomarker analysisOTHER
mass spectrometryOTHER
medical chart reviewOTHER
evaluation of cancer risk factorsPROCEDURE

Eligibility Criteria

Age19 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingBreast Carcinoma In Situ

Interventions

Chromatography, High Pressure LiquidMass Spectrometry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Chromatography, LiquidChromatographyChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Sandhya Pruthi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 20, 2005

Primary Completion

June 17, 2010

Study Completion

June 30, 2015

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations

US(1)