NCT00898703

Brief Summary

RATIONALE: Studying samples of blood in the laboratory from patients with current or previous cancer may help doctors learn more about biomarkers related to cancer. PURPOSE: This research study is looking at blood samples in women with breast cancer or a history of breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2001

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

August 1, 2001

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
2.2 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
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

5.6 years

First QC Date

May 9, 2009

Last Update Submit

December 13, 2012

Conditions

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • Comparison of levels of peripheral blood (PB) circulating endothelial cells (CEC) and plasma angiogenic factors between patients with active, measurable breast cancer vs prior history of breast cancer with no evidence of active disease

Secondary Outcomes (1)

  • Correlation of CEC and plasma angiogenic factors with response to tumor to a chemotherapy regimen

Interventions

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women with breast cancer or a history of breast cancer

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Receiving treatment for measurable breast cancer at the Arizona Cancer Center Clinic * Being followed for a prior history of breast cancer (with no evidence of active disease) at the Arizona Cancer Center * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Not pregnant or nursing PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Flow CytometryImmunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesImmunoassayImmunologic TechniquesImmunohistochemistryMolecular Probe Techniques

Study Officials

  • Alison T. Stopeck, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

August 1, 2001

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations