Lymph Fluid and Blood Collection for Identification of Novel Biomarkers

Adenocarcinoma of the Breast Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01075607
• Other study ID #: 0911-04
• Status: Terminated
• Phase: N/A
• First received: February 24, 2010
• Last updated: March 27, 2012
• Start date: April 2010
• Est. completion date: April 2022

Study information

• Verified date: March 2012
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 2022
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Breast
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification and Validation of Metastasis Protein Markers	Lymph fluid collected at surgery; blood collected at surgery and then every 6 months for 5 years.	Every 6 mo. for 5 years	No