NCT01075607

Lymph Fluid and Blood Collection for Identification of Novel Biomarkers

The Comparison of Lymph Fluid and Blood From Metastatic and Non-metastatic Invasive Breast Cancer Patients for Identification of Novel Biomarkers

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to identify and validate metastasis protein markers in lymph collected from women with metastatic breast cancer. We will examine peripheral blood for the presence of these identified markers in order to develop a user friendly clinical test to detect metastasis and to evaluate response to therapy.

Detailed description

The goal of the study is to identify node-negative breast cancer patients who are unlikely to benefit from adjuvant chemotherapy, thus saving them from the adverse effects of unnecessary treatment. We propose to identify and validate protein markers that can determine breast cancer recurrence and metastasis, based on an approach our group has recently found highly promising for biomarker discovery. The objective of our research is to identify and validate metastasis protein markers in lymph collected from vessels exiting from the primary tumor and prior to their entry into sentinel lymph node in women with metastatic breast cancer. Realizing that this novel procedure cannot be adopted for routine clinical use, we will examine the peripheral blood for the presence of these identified markers in order to develop a user friendly clinical test to detect metastasis and to evaluate response to therapy.

Conditions

• Adenocarcinoma of the Breast

Timeline

• Start date: 2010-04-01
• Primary completion: 2020-04-01
• Completion: 2022-04-01
• First posted: 2010-02-25
• Last updated: 2012-03-28

Locations

1 site across 1 country: United States