Lymph Fluid and Blood Collection for Identification of Novel Biomarkers

Stopped early

Conditions studied: Adenocarcinoma of the Breast

In brief

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.

Key facts

Study ID

NCT01075607

Run by

Indiana University

People needed

50

Starts

2010-04-01

Expected to finish

2022-04-01

Last updated by the study team

2012-03-28

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Indiana University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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