Proteomics Research of Breast Cancer Markers in Interstitial Fluid and Serum

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Pittsburgh
Sponsor:
Collaborator:
David Scaife Foundation
Information provided by (Responsible Party):
Min Sun, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01042548
First received: January 4, 2010
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

The current study is a case control study involving comparisons of tissue interstitial fluid from breast cancer and adjacent non-cancerous tissue as well as that from benign breast lesion and its adjacent non-diseased tissue for a distinguishable breast cancer profile. The purpose of this research is to collect fresh breast nodule/cancer and surrounding non-cancerous tissue for proteomic studies of the interstitial fluid to identify a profile distinguishing breast cancer which will also permit future research on stored interstitial fluid, blood or tissue samples. Specific markers identified from interstitial fluid study will be investigated in blood samples to develop serum markers for breast cancer diagnosis and prognosis. Additionally, we will perform both prospective and retrospective research on breast cancer involving clinical, demographic, epidemiologic information, treatment, follow-up and outcomes on breast nodule/cancer cases collected.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Proteomics Research of Breast Cancer Markers in Interstitial Fluid and Serum

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA

Subjects will be asked to allow us to collect an extra 2 tablespoons of blood at the time of pre-operative blood work. For those subjects with cancer who undergo surgery, a follow-up blood sample will be collected prior to chemotherapy, radiation, or hormonal therapy, and every six months afterwards at the time of their standard clinic/office visit for two years, then once a year for year 3-5. This will allow researchers to examine the samples to determine if blood changes over time after surgery, and what type of result may indicate a risk for recurrence.

Any remaining blood samples not used for the study will remain in the laboratory for future research.


Estimated Enrollment: 300
Study Start Date: September 2009
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who are receiving or seeking medical care at the UPMC St. Margaret for breast cancer will be invited to participate in the research study. Patients undergoing surgery for breast nodules suspected of being cancer or high risk lesions will also be asked to participate.

Criteria

Inclusion Criteria:

  • All subjects ≥ 18 years of age undergoing surgery for indeterminate breast nodules and all subjects with newly diagnosed breast cancer will be eligible to participate.

Exclusion Criteria:

  • Anyone < 18 years of age.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042548

Contacts
Contact: Cathy Van Every, BSN 412-781-3744 ext 112 vaneverycc@upmc.edu

Locations
United States, Pennsylvania
UPMC St. Margaret Recruiting
Pittsburgh, Pennsylvania, United States, 15215
Contact: Cathy Van Every, BSN    412-781-3744 ext 112    vaneverycc@upmc.edu   
Principal Investigator: Min Sun, MD, PhD         
Sponsors and Collaborators
University of Pittsburgh
David Scaife Foundation
  More Information

No publications provided

Responsible Party: Min Sun, MD, PD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01042548     History of Changes
Other Study ID Numbers: 09-028
Study First Received: January 4, 2010
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Proteomics
Breast Cancer Markers
Tissue Interstitial Fluid

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014