NCT00766454

Brief Summary

RATIONALE: Studying samples of urine and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This study is looking at urine and blood samples in 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
1,104

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 1998

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

November 1, 1998

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 1, 2017

Status Verified

October 1, 2015

Enrollment Period

11.2 years

First QC Date

October 3, 2008

Last Update Submit

July 27, 2017

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • Association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development

    Day 1

Interventions

DNA analysisGENETIC
mutation analysisGENETIC
polymorphism analysisGENETIC
laboratory biomarker analysisOTHER
medical chart reviewOTHER
questionnaire administrationOTHER
evaluation of cancer risk factorsPROCEDURE

Eligibility Criteria

AgeUp to 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those with newly diagnosed breast cancer who are planning to undergo a diagnostic biopsy or surgery.

You may qualify if:

  • Newly diagnosed breast cancer
  • Planning to undergo a diagnostic biopsy or surgery
  • Must have tumor tissue available
  • Hormone receptor status not specified
  • More than 6 months since prior chemotherapy or radiotherapy
  • Pre- or post-menopausal

You may not qualify if:

  • Psychiatric history that would preclude giving informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Steven A. Akman, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

November 1, 1998

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 1, 2017

Record last verified: 2015-10

Locations

US(1)