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Prospective Validation Trial of Circulating Tumor Cells (CTCs) in Women With Metastatic Breast Cancer

NCT00493350 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 660

Last updated 2012-07-31

No results posted yet for this study

Summary

Primary Objectives:

1. To validate the prognostic significance of circulating tumor cells (CTCs) in patients with newly diagnosed metastatic breast cancer (MBC).
2. To prospectively determine if assessment of CTCs can be used to stratify patients with MBC into two prognostic groups independent of existing methods i.e. hormone-receptor status, site of metastasis (e.g. visceral vs. non visceral) and treatment administered (e.g. chemotherapy vs. hormonal therapy).
3. To incorporate this information into the current TNM staging system by sub-classifying stage IV disease into two prognostic groups, Stage IVA and Stage IVB.

Secondary Objective:

1\. To perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes.

Conditions

Interventions

PROCEDURE

Blood Sample

1x4 ml (Serum Tube); 2x10 ml (CellSave Tube); 1x10 ml EDTA (Selected Centers)

Sponsors & Collaborators

  • Janssen Diagnostics, LLC

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Massimo Cristofanilli, MD · M.D. Anderson Cancer Center

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00493350 on ClinicalTrials.gov