Optical Biosensor for the Early Detection of Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
Optical Biosensor for the Early Detection of Breast Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls
Outcome Time Frame:
Baseline
Safety Issue:
No
Principal Investigator
John Yim, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Institutional Review Board
Study ID:
00080
NCT ID:
NCT00813878
Start Date:
July 2001
Completion Date:
Related Keywords:
- Breast Cancer
- breast cancer
- breast cancer in situ
- Breast Neoplasms
- Fibrocystic Breast Disease
Name | Location |
|---|---|
| City of Hope Medical Center | Duarte, California 91010 |
