Lymph Fluid and Blood Collection for Identification of Novel Biomarkers

This study has been terminated.
(Halted prematurely due to lack of funding.)
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01075607
First received: February 24, 2010
Last updated: March 27, 2012
Last verified: March 2012

February 24, 2010
March 27, 2012
April 2010
April 2020   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01075607 on ClinicalTrials.gov Archive Site
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Lymph Fluid and Blood Collection for Identification of Novel Biomarkers
The Comparison of Lymph Fluid and Blood From Metastatic and Non-metastatic Invasive Breast Cancer Patients 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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

Adenocarcinoma of the Breast
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
April 2022
April 2020   (final data collection date for primary outcome measure)

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.
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01075607
0911-04
No
Indiana University
Indiana University
Not Provided
Principal Investigator: Monet Bowling, MD Indiana University
Indiana University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP