Peptide Profiles of Women Undergoing Breast Biopsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00587821
First received: December 21, 2007
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Other: Blood draw

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Peptide Profiles of Women Undergoing Breast Biopsy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To identify the peptide profile associated with a diagnosis of malignancy on breast biopsy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 571
Study Start Date: January 2006
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
The first 250 samples will be used as a training set and results of these breast biopsies (benign or malignant) will be used to determine the peptide profile characteristic of a diagnosis of breast cancer on biopsy.
Other: Blood draw
Peptide profiles from blood samples of all subjects will be determined by mass spectrometric analysis.
2
The predictive capacity of this profile will then be prospectively assessed using the next 250 samples, which will serve as a validation set. Subjects who are candidates for enrollment on cohort B of this study (metastatic disease)
Other: Blood draw
Peptide profiles from blood samples of all subjects will be determined by mass spectrometric analysis.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC). If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Other potential subjects will be informed of the study by her treating professional at the time she is told of the need for a biopsy. Lists of patients scheduled for biopsy will be reviewed by study personnel on a weekly basis.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587821

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Mark Robson, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00587821     History of Changes
Other Study ID Numbers: 06-003
Study First Received: December 21, 2007
Last Updated: December 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast Cancer
Breast biopsy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014