NCT00393341

Brief Summary

We propose to quantitate endothelial progenitor cells (EPCs) in early and advanced breast cancer patients. Peripheral blood will be drawn from the eligible patients. Different type of EPCs will be isolated from the blood and quantitated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

2.6 years

First QC Date

October 25, 2006

Last Update Submit

August 27, 2015

Conditions

Breast Cancer Stage IVBreast Cancer Stage IBreast Cancer Stage II

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • To quantitate endothelial progenitor cells (EPCs) in early and advanced breast cancer patients. Different type of EPCs will be isolated from the blood and quantitated.

    Day 1

Study Arms (2)

Case

Women with breast cancer

Procedure: Blood Draw

Control

Women without breast cancer

Procedure: Blood Draw

Interventions

Blood DrawPROCEDURE

Blood sample will be drawn from a vein in the arm.

CaseControl

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women 18 or older with breast cancer recieving treatment at IUSCC and willing to donate a blood sample and complete consent form.

You may qualify if:

  • Diagnosis of metastatic breast cancer(stage IV), or women with a history of Stage I or II breast cancer disease who are currently disease free Women greater than or equal to 18 years of age Ability to understand and the willingness to sign an informed consent

You may not qualify if:

  • Chemotherapy, radiation, or surgery within the past 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • George W Sledge, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ballve Lantero Professor of Oncology

Study Record Dates

First Submitted

October 25, 2006

First Posted

October 27, 2006

Study Start

October 1, 2006

Primary Completion

May 1, 2009

Study Completion

August 1, 2009

Last Updated

August 31, 2015

Record last verified: 2015-08

Locations

US(1)