Lymph Fluid and Blood Collection for Identification of Novel Biomarkers

Terminated

• Conditions: Adenocarcinoma of the Breast

• Registration Number: NCT01075607
• Lead Sponsor: Indiana University

Brief 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.

Study Timeline

• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-25
• Study Start: 2010-04
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-27
• Last Update Posted: 2012-03-28
• Primary Completion: 2020-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Women, age greater than or equal to 18, with histologically and/or cytologically confirmed diagnosis of adenocarcinoma of the breast with metastatic (node positive) and/or non-metastatic (node negative) breast cancer.
• No prior chemotherapy treatment.
• Women, age greater than or equal to 18, with carcinoma in situ that opted for mastectomy.
• Able to provide informed consent and HIPAA authorization.

Exclusion Criteria

• Hormone therapy in the past six months. Birth control pill use is allowed.
• History of radiation therapy to the chest.
• Previous or current use of aromatase inhibitor (AI) or Selective Estrogen Receptor Modulator (SERM) medication.
• History of chemotherapy for breast or other cancers.
• Pregnant or breast-feeding.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification and Validation of Metastasis Protein Markers	Every 6 mo. for 5 years	Lymph fluid collected at surgery; blood collected at surgery and then every 6 months for 5 years.

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States