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

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT01042548
Collaborator
David Scaife Foundation (Other)
300
Enrollment
1
Location
181.9
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and Serum
    Actual Study Start Date :
    Feb 3, 2010
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 UPMC St. Margaret Pittsburgh Pennsylvania United States 15215

      Sponsors and Collaborators

      • University of Pittsburgh
      • David Scaife Foundation

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Min Sun, MD, PD, University of Pittsburgh
      ClinicalTrials.gov Identifier:
      NCT01042548
      Other Study ID Numbers:
      • 09-028
      First Posted:
      Jan 5, 2010
      Last Update Posted:
      Apr 15, 2022
      Last Verified:
      Apr 1, 2022
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Keywords provided by Min Sun, MD, PD, University of Pittsburgh
      Proteomics
      Breast Cancer Markers
      Tissue Interstitial Fluid
      Additional relevant MeSH terms:
      Breast Neoplasms

      Study Results

      No Results Posted as of Apr 15, 2022