Breast CancerNCT00813878
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
An observational study of Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- protein analysis, protein expression analysis and proteomic profiling
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010-3000
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- protein analysis, protein expression analysis, proteomic profiling, diagnostic laboratory biomarker analysis, immunohistochemistry staining method
- Keywords
- breast cancer, breast cancer in situ
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein analysisGenetic
protein analysis
protein expression analysisGenetic
protein expression analysis
proteomic profilingGenetic
proteomic profiling
diagnostic laboratory biomarker analysisOther
Performed one time on study
immunohistochemistry staining methodOther
Performed one time on study
liquid chromatographyOther
Performed on samples collected one time on study
mass spectrometryOther
Performed on samples collected one time on study
fine-needle aspirationProcedure or surgery
Samples collected one time on study at the appointment for fine-needle aspiration where applicable
needle biopsyProcedure or surgery
Samples collected one time on study at the appointment for needle biopsy where applicable
radiomammographyProcedure or surgery
Samples collected one time on study at the appointment for radiomammography where applicable
| Study group | Role | What they receive |
|---|---|---|
| Normal participants | Not described Receives: 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 | |
| Breast Cancer Patients | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls
Measured: Baseline
Sensitivity and specificity of measuring CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls
Measured: 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
Measured: Baseline
Profile of proteins present in fluid from affected vs unaffected breasts as assessed by mass spectrometry
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startJul 2001
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Closed due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John Yim, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813878
- Sponsor's protocol ID
- 00080
- Other IDs
- P30CA033572, CHNMC-00080, CDR0000629067
- Status last verified
- Oct 2017
- First submitted
- 20 Dec 2008
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Biosensor for the Early Detection of Breast Cancer
- ClinicalTrials.gov ID
- NCT00813878
- Acronym / sponsor ID
- 00080
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breast cancer in situ
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Closed due to low accrual
- Enrolment
- 126 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2001
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal participants | – | 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 |
| Breast Cancer Patients | – | 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 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein analysisprotein analysis | Genetic | Breast Cancer Patients, Normal participants |
| protein expression analysisprotein expression analysis | Genetic | Breast Cancer Patients, Normal participants |
| proteomic profilingproteomic profiling | Genetic | Breast Cancer Patients, Normal participants |
| diagnostic laboratory biomarker analysisPerformed one time on study | Other | Breast Cancer Patients, Normal participants |
| immunohistochemistry staining methodPerformed one time on study | Other | Breast Cancer Patients, Normal participants |
| liquid chromatographyPerformed on samples collected one time on study | Other | Breast Cancer Patients, Normal participants |
| mass spectrometryPerformed on samples collected one time on study | Other | Breast Cancer Patients, Normal participants |
| fine-needle aspirationSamples collected one time on study at the appointment for fine-needle aspiration where applicable | Procedure or surgery | Breast Cancer Patients, Normal participants |
| needle biopsySamples collected one time on study at the appointment for needle biopsy where applicable | Procedure or surgery | Breast Cancer Patients, Normal participants |
| radiomammographySamples collected one time on study at the appointment for radiomammography where applicable | Procedure or surgery | Breast Cancer Patients, Normal participants |
Primary outcome
CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls
Time frame: Baseline
Sensitivity and specificity of measuring CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls
Time frame: 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
Profile of proteins present in fluid from affected vs unaffected breasts as assessed by mass spectrometry
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Closed due to low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Yim, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Closed due to low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.