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NCT00355316 · ClinicalTrials.gov registry record · NA

A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients

A NA study of Breast Neoplasms, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
224
Enrollment target
2
Study locations

NCT00355316 is a NA study of Breast Neoplasms that has completed, run by Washington University School of Medicine. The registered enrollment target is 224 participants, below the 567-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (60% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00355316, a NA study of Breast Neoplasms, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
224 participants
Enrollment target
2
Study locations

Study Summary

This study is designed to determine whether molecular detection of breast cancer cells in the peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of progression-free and overall survival. Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment. Multi-marker real-time RT-PCR analysis will be performed on peripheral blood specimens from 92 breast cancer patients and 120 healthy volunteers. Peripheral blood specimens from breast cancer patients will be obtained at the time of study entry (prior to initiation of systemic therapy) and at serial time points during follow-up. Subjects will be followed longitudinally until death, although the study has been powered so that the primary objective can be addressed after 12 months of follow-up. Healthy volunteers will be asked to provide a blood sample at time of enrollment but will not be followed.

Conditions Studied

Interventions

  • OTHER Blood draw

Study Locations (2)

Missouri

  • Washington University School of Medicine - St Louis

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 224 participants
Start Date 2005-11
Est. Completion 2013-02
Phase NA

What the Registry Record Tells You About NCT00355316

The ClinicalTrials.gov registry entry for NCT00355316 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 567-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (60% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Blood draw is the first listed.

NCT00355316 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Missouri, South Carolina.

Frequently Asked Questions

What is clinical trial NCT00355316 about?

NCT00355316 is a clinical study titled "A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients". This study is designed to determine whether molecular detection of breast cancer cells in the peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of progression-free and overall survival. Stage IV breast cancer patients who have measurable breast cancer metastases ...

What is the current status of trial NCT00355316?

This trial is currently completed. It is a NA study. The enrollment target is 224 participants. The study started on 2005-11. Estimated completion is 2013-02.

What conditions does trial NCT00355316 study?

This clinical trial studies the following conditions: Breast Neoplasms.

What interventions are being tested in trial NCT00355316?

The interventions under investigation include: Blood draw (OTHER).

Who is sponsoring clinical trial NCT00355316?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00355316 being conducted?

This trial has 2 study locations across Missouri, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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