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Proteomics Research of Breast Cancer Markers in Interstitial Fluid and Serum

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ClinicalTrials.gov Identifier: NCT01042548
Recruitment Status : Recruiting
First Posted : January 5, 2010
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
David Scaife Foundation
Information provided by (Responsible Party):
Min Sun, University of Pittsburgh

Study Description
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Brief Summary:
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 or disease
Breast Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Proteomics Research of Breast Cancer Markers in Interstitial Fluid and Serum
Study Start Date : September 2009
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): 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
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Responsible Party: Min Sun, MD, PD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01042548     History of Changes
Other Study ID Numbers: 09-028
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

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

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