Lymph Fluid and Blood Collection for Identification of Novel Biomarkers
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.
Adenocarcinoma of the Breast
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||The Comparison of Lymph Fluid and Blood From Metastatic and Non-metastatic Invasive Breast Cancer Patients for Identification of Novel Biomarkers|
- Identification and Validation of Metastasis Protein Markers [ Time Frame: Every 6 mo. for 5 years ] [ Designated as safety issue: No ]Lymph fluid collected at surgery; blood collected at surgery and then every 6 months for 5 years.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||April 2022|
|Estimated Primary Completion Date:||April 2020 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075607
|United States, Indiana|
|Indiana University Hospital|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Monet Bowling, MD||Indiana University|