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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

December 20, 2008
October 11, 2012
July 2001
February 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00813878 on ClinicalTrials.gov Archive Site
Not Provided
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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
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • 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
  • Placebo Comparator: Normal participants
    Interventions:
    • 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
  • Active Comparator: Breast Cancer Patients
    Interventions:
    • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
126
Not Provided
February 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00813878
00080, P30CA033572, CHNMC-00080, CDR0000629067
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: John Yim, MD Beckman Research Institute
City of Hope Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP