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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01042548
• Other study ID #: 09-028
• Status: Recruiting
• Start date: February 3, 2010
• Est. completion date: April 2028

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: Laura Chiesa
• Phone: 412-831-1320
• Email: powersl2[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	UPMC St. Margaret	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	David Scaife Foundation

Country where clinical trial is conducted

United States,