Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer

NCT00897338 | Completed

• 3 other identifiers: J0737 CDR0000571962P30CA006973JHOC-J0737
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Studying samples of blood and pleural or peritoneal fluid from patients with metastatic breast cancer in the laboratory may help doctors identify biomarkers related to breast cancer and learn more about how breast cancer begins and spreads in the body. PURPOSE: This research study is looking at a new way of identifying circulating breast cancer cells in blood and in pleural or peritoneal fluid in women with metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility of novel technique to identify and isolate circulating breast cancer cells

  Baseline

• Comparison of this novel technique with the CellSearch™ system

  Baseline

Interventions

flow cytometry OTHER

laboratory analysis

fluorescence activated cell sorting OTHER

laboratory analysis

immunohistochemistry staining method OTHER

laboratory analysis

immunologic technique OTHER

laboratory analysis

biomarker analysis OTHER

laboratory analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Metastatic breast cancer patients

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Metastatic disease (stage IV) * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-1000, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Flow Cytometry; Immunohistochemistry; Immunologic Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Histocytochemistry; Histological Techniques

Study Officials

• Vered Stearns, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: August 1, 2007
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

US (1)