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 has been terminated.
(Closed due to low accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00813878
First received: December 20, 2008
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Breast Cancer
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 Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Optical Biosensor for the Early Detection of Breast Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls [ Time Frame: Baseline ] [ 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 [ Time Frame: Baseline ] [ 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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Profile of proteins present in fluid from affected vs unaffected breasts as assessed by mass spectrometry [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: July 2001
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal participants Genetic: protein analysis
protein analysis
Genetic: protein expression analysis
protein expression analysis
Genetic: proteomic profiling
proteomic profiling
Other: diagnostic laboratory biomarker analysis
Performed one time on study
Other: immunohistochemistry staining method
Performed one time on study
Other: liquid chromatography
Performed on samples collected one time on study
Other: mass spectrometry
Performed on samples collected one time on study
Procedure: fine-needle aspiration
Samples collected one time on study at the appointment for fine-needle aspiration where applicable
Procedure: needle biopsy
Samples collected one time on study at the appointment for needle biopsy where applicable
Procedure: radiomammography
Samples collected one time on study at the appointment for radiomammography where applicable
Active Comparator: Breast Cancer Patients Genetic: protein analysis
protein analysis
Genetic: protein expression analysis
protein expression analysis
Genetic: proteomic profiling
proteomic profiling
Other: diagnostic laboratory biomarker analysis
Performed one time on study
Other: immunohistochemistry staining method
Performed one time on study
Other: liquid chromatography
Performed on samples collected one time on study
Other: mass spectrometry
Performed on samples collected one time on study
Procedure: fine-needle aspiration
Samples collected one time on study at the appointment for fine-needle aspiration where applicable
Procedure: needle biopsy
Samples collected one time on study at the appointment for needle biopsy where applicable
Procedure: radiomammography
Samples collected one time on study at the appointment for radiomammography where applicable

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00813878

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: John Yim, MD Beckman Research Institute
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00813878     History of Changes
Other Study ID Numbers: 00080, P30CA033572, CHNMC-00080, CDR0000629067
Study First Received: December 20, 2008
Last Updated: October 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
breast cancer
breast cancer in situ

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

ClinicalTrials.gov processed this record on August 26, 2014