Peptide Profiles of Women Undergoing Breast Biopsy

Breast Cancer Clinical Trial

Official title:

Peptide Profiles of Women Undergoing Breast Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587821
• Other study ID #: 06-003
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: December 18, 2013
• Start date: January 2006
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This study is being done to learn about blood proteins. We want to see if the blood proteins in women whose biopsies show breast cancer are different from the blood proteins in women whose biopsies do not show breast cancer. The goal of this study is to develop a blood test than can help detect breast cancers when they are very small and easy to cure.

Description:

Despite currently available screening techniques, only 63% of breast cancer cases are diagnosed at a localized stage, for which the 5-year survival rate exceeds 95% (1). Advances in breast imaging are occurring, but further efforts to detect breast cancer at an early stage would be beneficial. Recently, new technologies which use mass spectrometric analysis to characterize the overall pattern of peptide expression in the serum or plasma have been developed. Preliminary studies have suggested that peptide profiles can be used to differentiate cancer patients from those without cancer for a variety of malignancies including breast cancer. If mass spectrometric analysis is able to detect differences in peptide profiles between early stage breast cancers and normal controls, this technique could be developed as a screening modality.

The objective of the present study which is entitled "Peptide Profiles of Women Undergoing Breast Biopsy" is to determine whether the diagnosis of malignancy on breast biopsy is associated with a specific serum or plasma peptide profile which can be distinguished from the peptide profile associated with benign diagnoses on breast biopsy. To accomplish this, blood samples will be collected from 500 women undergoing breast biopsy and 100 women with metastatic disease. Samples will be obtained prior to the biopsies and analyzed by mass spectrometry. Residual material will be shared with investigators of the National Cancer Institute Clinical Proteomics Technology Assessment Consortium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female

• Age = or = to 18

Cohort A: Biopsy Cohort:

• Referred by a healthcare provider for breast biopsy

• No prior history of invasive breast cancer OR of ductal carcinoma in situ

• No prior history of other malignancies within 5 years except cervical dysplasia, squamous cell carcinoma of the skin or basal cell carcinoma of the skin Cohort B: Metastatic Disease Cohort - Diagnosis of stage IV breast cancer

Exclusion Criteria:

• Male

• Age < 18

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Blood draw
Peptide profiles from blood samples of all subjects will be determined by mass spectrometric analysis.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify the peptide profile associated with a diagnosis of malignancy on breast biopsy.		2 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center