Peptide Profiles of Women Undergoing Breast Biopsy

NCT00587821 | Completed

• 1 other identifier: 06-003
• Study Type: observational
• Target: 571
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Breast biopsy

Outcome Measures

Primary Outcomes (1)

• To identify the peptide profile associated with a diagnosis of malignancy on breast biopsy.

  2 years

Study Arms (2)

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

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

Interventions

Blood draw OTHER

Peptide profiles from blood samples of all subjects will be determined by mass spectrometric analysis.

1; 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Male
• Age \< 18

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mark Robson, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: January 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

US (1)