Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00355316
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2006-07-19
Brief Title:
A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Peripheral Blood Molecular Staging of Breast Cancer A Prospective Cohort Study Designed to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Peripheral Blood of Stage IV Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None