Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003854
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Brief Title:
Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer
PURPOSE Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer
PURPOSE Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer
Detailed Description:
OBJECTIVES
Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node micrometastases detected by immunohistochemistry in women with stage I or IIA breast cancer
Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients
Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin HE staining
Provide a mechanism for identifying women whose sentinel nodes contain metastases detected by HE so that these women can be considered as candidates for ACOSOG-Z0011
Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node micrometastases detected by immunohistochemistry in women with stage I or IIA breast cancer
Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients
Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin HE staining
Provide a mechanism for identifying women whose sentinel nodes contain metastases detected by HE so that these women can be considered as candidates for ACOSOG-Z0011
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067017 | REGISTRY | NCI Physician Data Query | None |
| GUMC-00152 | None | None | None |