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Lymph Fluid and Blood Collection for Identification of Novel Biomarkers

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ClinicalTrials.gov Identifier: NCT01075607
Recruitment Status : Terminated (Halted prematurely due to lack of funding.)
First Posted : February 25, 2010
Last Update Posted : March 28, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Adenocarcinoma of the Breast

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 Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Comparison of Lymph Fluid and Blood From Metastatic and Non-metastatic Invasive Breast Cancer Patients for Identification of Novel Biomarkers
Study Start Date : April 2010
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Identification and Validation of Metastasis Protein Markers [ Time Frame: Every 6 mo. for 5 years ]
    Lymph fluid collected at surgery; blood collected at surgery and then every 6 months for 5 years.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with adenocarcinoma of the breast - no prior chemotherapy treatment.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075607


Locations
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Monet Bowling, MD Indiana University

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01075607     History of Changes
Other Study ID Numbers: 0911-04
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012

Keywords provided by Indiana University:
Lymph fluid collection

Additional relevant MeSH terms:
Adenocarcinoma
Breast Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases