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
  Purpose

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
Adenocarcinoma of the Breast

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01075607     History of Changes
Other Study ID Numbers: 0911-04
Study First Received: February 24, 2010
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 20, 2014