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Clinical Trials/NCT01042548
NCT01042548
Recruiting
Not Applicable

Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and Serum

University of Pittsburgh1 site in 1 country300 target enrollmentFebruary 3, 2010
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Pittsburgh
Enrollment
300
Locations
1
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 3, 2010
End Date
April 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Min Sun

MD, PD

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • All subjects ≥ 18 years of age undergoing surgery for indeterminate breast nodules, breast tissue reduction, prophylactic mastectomy, and all subjects with newly diagnosed invasive breast cancer will be eligible to participate. If invasive breast cancer or suspicion of invasive breast cancer, target lesion must measure ≥ 1.0 cm on breast imaging before core biopsy.

Exclusion Criteria

  • Anyone \< 18 years of age.
  • Multiple synchronous primary malignancies from different organ systems.

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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