NCT00813878

Brief 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, breast diagnostic studies, or treatment for benign breast disease.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

11.2 years

First QC Date

December 20, 2008

Last Update Submit

October 11, 2017

Conditions

Breast Cancer

Keywords

breast cancerbreast cancer in situ

Outcome Measures

Primary Outcomes (4)

  • CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls

    Baseline

  • Sensitivity and specificity of measuring CEA levels in nipple secretions and blood samples from breast cancer patients and normal controls

    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

    Baseline

  • Profile of proteins present in fluid from affected vs unaffected breasts as assessed by mass spectrometry

    Baseline

Study Arms (2)

Normal participants

Genetic: protein analysisGenetic: protein expression analysisGenetic: proteomic profilingOther: diagnostic laboratory biomarker analysisOther: immunohistochemistry staining methodOther: liquid chromatographyOther: mass spectrometryProcedure: fine-needle aspirationProcedure: needle biopsyProcedure: radiomammography

Breast Cancer Patients

Genetic: protein analysisGenetic: protein expression analysisGenetic: proteomic profilingOther: diagnostic laboratory biomarker analysisOther: immunohistochemistry staining methodOther: liquid chromatographyOther: mass spectrometryProcedure: fine-needle aspirationProcedure: needle biopsyProcedure: radiomammography

Interventions

protein analysisGENETIC

protein analysis

Breast Cancer PatientsNormal participants
protein expression analysisGENETIC

protein expression analysis

Breast Cancer PatientsNormal participants
proteomic profilingGENETIC

proteomic profiling

Breast Cancer PatientsNormal participants
diagnostic laboratory biomarker analysisOTHER

Performed one time on study

Breast Cancer PatientsNormal participants
immunohistochemistry staining methodOTHER

Performed one time on study

Breast Cancer PatientsNormal participants
liquid chromatographyOTHER

Performed on samples collected one time on study

Breast Cancer PatientsNormal participants
mass spectrometryOTHER

Performed on samples collected one time on study

Breast Cancer PatientsNormal participants
fine-needle aspirationPROCEDURE

Samples collected one time on study at the appointment for fine-needle aspiration where applicable

Breast Cancer PatientsNormal participants
needle biopsyPROCEDURE

Samples collected one time on study at the appointment for needle biopsy where applicable

Breast Cancer PatientsNormal participants
radiomammographyPROCEDURE

Samples collected one time on study at the appointment for radiomammography where applicable

Breast Cancer PatientsNormal participants

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Carcinoma In Situ

Interventions

ImmunohistochemistryChromatography, LiquidMass SpectrometryBiopsy, Fine-NeedleBiopsy, Needle

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic TechniquesChromatographyChemistry Techniques, AnalyticalBiopsyCytodiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePunctures

Study Officials

  • John Yim, MD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2008

First Posted

December 23, 2008

Study Start

July 1, 2001

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)