Recruiting

Breast Cancer Markers

Sponsor:

University of Pittsburgh

Code:

NCT01042548

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT01042548

Start date

Feb 3, 2010

Status verified date

May, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Laura Chiesa

412-831-1320powersl2@upmc.edu

Min Sun, MD, PhD

412-781-3744sunxmx@UPMC.EDU

Locations

UPMC St. Margaret

Recruiting

Pittsburgh, Pennsylvania, United States, 15215

Contacts

Laura Chiesa

412-831-1320powersl2@upmc.edu

Principal Investigator:

Min Sun, MD, PhD

More Information

Sponsor

University of Pittsburgh

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Proteomics
  • Breast Cancer Markers
  • Tissue Interstitial Fluid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-05-07.