NCT00959244

Brief Summary

RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is looking at urine samples from women with newly diagnosed breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Shorter than P25 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

February 2, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2009

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

August 13, 2009

Last Update Submit

August 29, 2023

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • Estrogen compounds

    Estrogen compounds in urine

    at baseline at 6 months and annually

Interventions

high performance liquid chromatographyOTHER

Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.

laboratory biomarker analysisOTHER

The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.

mass spectrometryOTHER

Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.

medical chart reviewOTHER

Information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, menopausal status and breast disease, body mass index, age at menarche, menopausal status (pre- or peri- menopausal or postmenopausal), age at menopause if applicable, chemotherapy regimen (if applicable), radiation therapy (if applicable), smoking history, alcohol consumption, pregnancy history including age at each pregnancy, lactation, history of benign breast disease, hysterectomy and disease type.

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with breast cancer

You may qualify if:

  • Newly diagnosed ductal carcinoma in situ or invasive breast cancer
  • Urine biospecimens available from participation in protocol UNMC-08105 (IRB#311-06), the Breast Cancer Collaborative Registry (BCCR), which included treatment with tamoxifen or an aromatase inhibitor
  • o Urine specimens were collected at baseline, 6 months, and then annually
  • Estrogen receptor or progesterone receptor positive
  • ECOG performance status 0-2

You may not qualify if:

  • Not pregnant or nursing
  • No concurrent use of estrogen(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eppley Cancer Center, University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

Chromatography, High Pressure LiquidMass Spectrometry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Chromatography, LiquidChromatographyChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Ercole Cavalieri, DSc

    Eppley Cancer Center, University of Nebraska Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

February 2, 2009

Primary Completion

September 25, 2009

Study Completion

September 25, 2009

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

US(1)