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

NCT01042548 | Recruiting DMC

• 1 other identifier: 09-028
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Proteomics; Breast Cancer Markers; Tissue Interstitial Fluid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• David Scaife Foundation: collaborator

Study Sites (1)

UPMC St. Margaret

Pittsburgh, Pennsylvania, 15215, United States

RECRUITING

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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Laura Chiesa

CONTACT

412-831-1320; powersl2@upmc.edu

Min Sun, MD, PhD

CONTACT

412-781-3744; sunxmx@UPMC.EDU

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PD

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: February 3, 2010
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)