Nipple Secretion Samples in Detecting Breast Cancer in Patients and Healthy Participants Undergoing Breast Cancer Screening, Breast Diagnostic Studies, or Treatment for Benign Breast Disease

Nipple Secretion Samples in Detecting Breast Cancer in Patients and Healthy Participants Undergoing Breast Cancer Screening, Breast Diagnostic Studies, or Treatment for Benign Breast Disease

This study is currently recruiting participants.
Study NCT00813878 Information provided by National Cancer Institute (NCI)
First Received: December 20, 2008 Last Updated: June 23, 2009 History of Changes

Tracking Information
First Received Date ICMJE December 20, 2008
Last Updated Date June 23, 2009
Start Date ICMJE July 2001
Estimated Primary Completion Date March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE
(submitted: December 20, 2008) CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls [ Designated as safety issue: No ]
Sensitivity and specificity of measuring CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls [ Designated as safety issue: No ]
Comparison of optical biosensor CEA levels with CEA levels measured by standard protein assays in blood samples and nipple secretions from breast cancer patients and normal controls [ Designated as safety issue: No ]
Profile of proteins present in fluid from affected vs unaffected breasts as assessed by mass spectrometry [ Designated as safety issue: No ]

Original Primary Outcome Measures ICMJE Same as current
Change History Complete list of historical versions of study NCT00813878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE
Original Secondary Outcome Measures ICMJE

Descriptive Information
Brief Title ICMJE Nipple Secretion Samples in Detecting Breast Cancer in Patients and Healthy Participants Undergoing Breast Cancer Screening, Breast Diagnostic Studies, or Treatment for Benign Breast Disease
Official Title ICMJE Optical Biosensor for the Early Detection of Breast Cancer
Brief Summary RATIONALE: Diagnostic procedures that measure biomarker levels in nipple section and blood samples, may help in the early detection of breast cancer.

PURPOSE: This clinical trial is studying nipple secretion samples in detecting breast cancer in patients and healthy participants undergoing breast cancer screening, breast diagnostic studies, or treatment for benign breast disease.

Detailed Description OBJECTIVES:

To determine CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls.
To determine the sensitivity and specificity of measuring CEA levels in nipple secretions and blood samples for the detection of breast cancer.
To validate the optical biosensor CEA levels measured in blood and nipple secretions in breast cancer patients and normal controls compared with standard protein assays.
To develop a profile of proteins present in affected vs unaffected breasts using mass spectrometry.
OUTLINE: Patients and participants undergo nipple secretion and blood sample collection at baseline and at 1 month for evaluation of levels of carcinoembryonic antigen (CEA) and patterns of protein expression that may indicate the presence of early-stage breast cancer. Nipple secretions are obtained from both the affected and unaffected breasts via capillary, aspiration (nipple aspirate fluid [NAF]), and nipple blot . CEA levels are measured in serum samples, NAF, and other nipple secretions using standard CEA protein assays. Nipple secretions obtained by nipple blot are analyzed by nipple blot assay to determine the feasibility of using this technique. The results of the nipple blot assay are then compared with the results of standard protein assays to evaluate the sensitivity and specificity of the nipple blot test. CEA expression is also determined in breast tissue specimens obtained from patients undergoing diagnostic biopsy. Specimens are examined by IHC for tissue CEA levels. Proteomic profiles in NAF and serum samples are measured using liquid chromatography mass spectrometry and then compared with proteomic profiles in normal healthy controls.

Once the feasibility of the nipple blot assay has been determined, an optical biosensor will be developed to detect fluorescent-labeled antibodies directed against CEA found in serum and breast sections. Optical biosensor CEA levels measured in breast cancer patients and normal controls will then be compared to standard protein assays for evaluation of the sensitivity and specificity of biosensor measurements.

After completion of study intervention, patients and participants are followed for 5 years.

Study Phase
Study Type ICMJE Interventional
Study Design ICMJE Diagnostic
Condition ICMJE Breast Cancer
Intervention ICMJE Genetic: protein analysis
Genetic: protein expression analysis
Genetic: proteomic profiling
Other: diagnostic laboratory biomarker analysis
Other: immunohistochemistry staining method
Other: liquid chromatography
Other: mass spectrometry
Procedure: fine-needle aspiration
Procedure: needle biopsy
Procedure: radiomammography

Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ICMJE Recruiting
Estimated Enrollment ICMJE 375
Completion Date
Estimated Primary Completion Date March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE DISEASE CHARACTERISTICS:

Referred to the Women's Health Center at the City of Hope National Medical Center for breast cancer screening, breast diagnostic studies, or treatment of breast disease
Meets 1 of the following criteria:

Asymptomatic and undergoing screening mammography (normal controls)
Symptomatic and undergoing diagnostic mammography
History of an abnormal mammogram and undergoing stereotactic or ultrasound-guided fine-needle aspiration or core needle biopsy
Recently diagnosed biopsy-proven unilateral breast cancer prior to initiation of surgical or systemic therapy
No prior breast surgery or surgical biopsy that removed the current breast pathology
No prior breast reconstruction or breast reduction surgery that altered the ductal drainage pattern in the affected breast
PATIENT CHARACTERISTICS:

No other cancer within the past 5 years except skin cancer
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Gender Female
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ICMJE
Location Countries ICMJE United States

Administrative Information
NCT ID ICMJE NCT00813878
Responsible Party John Shively, City of Hope Comprehensive Cancer Center
Study ID Numbers ICMJE CDR0000629067, CHNMC-00080
Study Sponsor ICMJE Beckman Research Institute
Collaborators ICMJE National Cancer Institute (NCI)
Investigators ICMJE Principal Investigator: John Shively, PhD Beckman Research Institute

Information Provided By National Cancer Institute (NCI)
Verification Date June 2009