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

Brief Summary

Official Title: “Optical Biosensor for the Early Detection of Breast Cancer”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
  • Study Primary Completion Date: February 2013

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: Normal participants
  • Active Comparator: Breast Cancer Patients

Outcome Measures for this Clinical Trial

Primary Measures

  • CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls
    • Time Frame: Baseline
      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
      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
      Safety Issue?: No
  • Profile of proteins present in fluid from affected vs unaffected breasts as assessed by mass spectrometry
    • Time Frame: Baseline
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • City of Hope Medical Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John Yim, MD, Principal Investigator, Beckman Research Institute

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00813878