Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-27 @ 6:22 AM
Study NCT ID:
NCT00493350
Status:
COMPLETED
Last Update Posted:
2012-07-31
First Post:
2007-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Validation Trial of Circulating Tumor Cells (CTCs) in Women With Metastatic Breast Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
International Stage IV Stratification Study (ISSS): Prospective Validation Trial of Circulating Tumor Cells (CTCs) as Prognostic and Predictive Markers in Women With Metastatic Breast Cancer About to Start First-Line Treatment
Status:
COMPLETED
Status Verified Date:
2012-07
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:
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.
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.
Detailed Description:
Patients with tumors that have spread to other parts of the body and who are about to start systemic treatment will be eligible to take part in this study.
As is standard of care, you will have an evaluation of your disease through CT scans, bone scans, and PET scans. Before you begin your routine treatment, participants in this study will have 3 teaspoons of blood drawn at an M. D. Anderson clinic. This will be the only blood draw required for this study. You will then begin receiving standard therapy for your disease as decided by your treating physician.
You will have follow-ups with either your physician or through the research personnel (by phone calls by the research nurse) at 3, 6, 12, 18, and 36 months. After 36 months, follow-up will continue indefinitely at your doctor's discretion. At these follow-ups, your medical record will be reviewed to gather information for this study.
One of the blood samples will be preserved and used for research and development purposes specifically related to this study. This research includes also analysis of the tumor gene profiling. This study will be done to better understand the biology of metastatic breast cancer. Neither participants nor the doctors taking care of them will be told about the results of the research.
This is an investigational study. CellSearch (the technology used to count circulating tumor cells) is approved by the FDA for breast cancer prognosis. About 660 patients will take part in this multicenter study. About 100 patients will be enrolled at M. D. Anderson.
As is standard of care, you will have an evaluation of your disease through CT scans, bone scans, and PET scans. Before you begin your routine treatment, participants in this study will have 3 teaspoons of blood drawn at an M. D. Anderson clinic. This will be the only blood draw required for this study. You will then begin receiving standard therapy for your disease as decided by your treating physician.
You will have follow-ups with either your physician or through the research personnel (by phone calls by the research nurse) at 3, 6, 12, 18, and 36 months. After 36 months, follow-up will continue indefinitely at your doctor's discretion. At these follow-ups, your medical record will be reviewed to gather information for this study.
One of the blood samples will be preserved and used for research and development purposes specifically related to this study. This research includes also analysis of the tumor gene profiling. This study will be done to better understand the biology of metastatic breast cancer. Neither participants nor the doctors taking care of them will be told about the results of the research.
This is an investigational study. CellSearch (the technology used to count circulating tumor cells) is approved by the FDA for breast cancer prognosis. About 660 patients will take part in this multicenter study. About 100 patients will be enrolled at M. D. Anderson.
Study Oversight
Has Oversight DMC:
False
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?: