Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For... | NCT00083018

Studies
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer

NCT00083018

Sponsor

Royal Marsden NHS Foundation Trust

Status

Unknown status

Last Update Posted

Aug 26, 2013Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

cytogenetic analysis
proteomic profiling
cytology specimen collection procedure
immunohistochemistry staining method
laboratory biomarker analysis
breast duct lavage

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 14, 2004

First Submission Date that Met QC Criteria

May 14, 2004

First Posted Date

May 17, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2013

Last Update Posted Date

Aug 26, 2013Estimated

Description Module

Brief Summary

RATIONALE: Diagnostic procedures, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect and assess breast cancer cells early and plan more effective treatment.

PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct endoscopy work in assessing cancer cells in women who are undergoing surgery for breast cancer.

Detailed Description

OBJECTIVES:

Primary

Correlate the cell yield and morphology findings from ductal lavage with duct endoscopy findings and surgical pathology findings in women with breast cancer.
Determine the sensitivity and specificity of nipple aspiration, ductal lavage, and duct endoscopy in detecting established breast cancer in these patients.

Secondary

Compare the intraduct environment of cancer-involved ducts in the affected breast vs the ductal systems in the contralateral breast of these patients.
Perform immunohistochemical analysis (including estrogen receptor, progesterone receptor, HER2-neu receptor, epidermal growth factor receptor, p53, and proliferation marker expression) for markers potentially associated with breast cancer in these patients.
Determine potential molecular markers of malignancy by gene methylation, gene expression, and proteomics in these patients.
Compare the biochemistry and protein analysis of the intraductal fluid vs serum analysis in these patients.

OUTLINE: Patients undergo nipple aspiration, ductal lavage, and duct endoscopy under general anesthesia immediately before breast surgery. Fluid and tissue obtained are examined for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation, gene expression arrays, and proteomic profiling.

Patients are followed at 24 hours and at 1 week.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer
No metastatic disease
No inflammatory breast cancer
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Female

Menopausal status

Not specified

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No active infection or inflammation in the breast under study
No known allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine
No severe illness
Not unconscious
No mental illness or handicap
No nursing within the past 12 months
Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

No prior breast implantation on side of proposed lavage
No prior subareolar (e.g., papilloma resections, biopsies, or fine needle aspirations) or other surgery that may disrupt the ductal systems within 2 cm of the nipple
- Biopsies and fine-needle aspirations > 2 cm from the nipple are allowed

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Measure	Description	Time Frame
Correlation of cell yields and morphology in ductal lavage with duct endoscopy appearances and findings
Sensitivity and specificity of ductal lavage with or without ductoscopy in detecting atypical cells
Comparison of cell yields vs final surgical pathology of the operative specimens

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D020732	Cytogenetic Analysis
D007150	Immunohistochemistry

ID	Term
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques
D005821	Genetic Techniques
D006651	Histocytochemistry
D006652	Histological Techniques
D007158	Immunologic Techniques

Name	Type	Description	Arm Group Labels	Other Names
cytogenetic analysis	Genetic
proteomic profiling	Genetic
cytology specimen collection procedure	Other
immunohistochemistry staining method	Other
laboratory biomarker analysis	Other
breast duct lavage	Procedure

ID	Type	Description	Link
RMNHS-2283
EU-20353