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

October 11, 2017 updated by: City of Hope Medical Center

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal participants
Genetic: protein expression analysis
protein expression analysis
Genetic: proteomic profiling
proteomic profiling
Genetic: protein analysis
protein analysis
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
Breast Cancer Patients
Genetic: protein expression analysis
protein expression analysis
Genetic: proteomic profiling
proteomic profiling
Genetic: protein analysis
protein analysis
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls
Time Frame: Baseline
Baseline
Sensitivity and specificity of measuring CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls
Time Frame: Baseline
Baseline
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
Baseline
Profile of proteins present in fluid from affected vs unaffected breasts as assessed by mass spectrometry
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: John Yim, MD, City of Hope Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 20, 2008

First Submitted That Met QC Criteria

December 20, 2008

First Posted (Estimate)

December 23, 2008

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00080
  • P30CA033572 (U.S. NIH Grant/Contract)
  • CHNMC-00080
  • CDR0000629067 (Registry Identifier: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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