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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Laura Chiesa; Phone Number: 412-831-1320; Email: powersl2@upmc.edu
• Study Contact Backup: Name: Min Sun, MD, PhD; Phone Number: 412-781-3744; Email: sunxmx@UPMC.EDU

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15215
      • Recruiting
      • UPMC St. Margaret
      • Contact: Laura Chiesa; Phone Number: 412-831-1320; Email: powersl2@upmc.edu
      • Contact: Min Sun, MD, PhD
      • Principal Investigator: Min Sun, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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, breast tissue reduction, or prophylactic mastectomy will also be asked to participate.

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: David Scaife Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2010
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: January 4, 2010
• First Submitted That Met QC Criteria: January 4, 2010
• First Posted (Estimated): January 5, 2010

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Proteomics; Breast Cancer Markers; Tissue Interstitial Fluid
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 09-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO