NCT00089323

Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer

Bone Marrow Analysis In Early-Stage Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,630 (actual)
• Sponsor: NSABP Foundation Inc · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Diagnostic procedures that detect tumor cells in the bone marrow may help doctors predict disease recurrence and plan more effective treatment. PURPOSE: This clinical trial is studying how well diagnostic procedures work in detecting tumor cells in the bone marrow of patients who have undergone surgery for stage I, stage II, or stage IIIA breast cancer.

Detailed description

OBJECTIVES: Primary * Determine the relative risk of death associated with the presence of tumor cells in the bone marrow of patients with stage I, II, or IIIA breast cancer undergoing surgery and bone marrow analysis using multicolor fluorescence immunocytochemistry and bright field immunocytochemistry. Secondary * Compare multicolor fluorescence immunocytochemistry vs bright field immunocytochemistry in the detection of bone marrow micrometastases in these patients. OUTLINE: This is a multicenter study. Patients undergo bone marrow aspiration during surgical resection of the primary tumor. Bone marrow cells and tumor samples are analyzed using bright field immunocytochemistry and multicolor fluorescence immunocytochemistry. Patients are followed every 12 months for up to 10 years. PROJECTED ACCRUAL: A total of 1,634 patients will be accrued for this study within 3 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Bone Marrow Aspiration

Timeline

• Start date: 2007-01-01
• Primary completion: 2018-07-01
• Completion: 2018-08-01
• First posted: 2004-08-05
• Last updated: 2021-10-11

Locations

53 sites across 2 countries: United States, Canada