Lymph Fluid and Blood Collection for Identification of Novel Biomarkers

NCT01075607 | Terminated

• 1 other identifier: 0911-04
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Breast

Keywords

Lymph fluid collection

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with adenocarcinoma of the breast - no prior chemotherapy treatment.

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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Monet Bowling, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2022
• Last Updated: March 28, 2012

Record last verified: 2012-03

Locations

US (1)