Nipple Aspiration, Ductal Lavage, and Duct Endoscopy in S... | NCT00081003

Studies
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy in Screening Women at Moderate-to-High Risk of Developing Breast Cancer

NCT00081003

Sponsor

Royal Marsden NHS Foundation Trust

Status

Completed

Last Update Posted

Jul 23, 2014Estimated

Enrollment

1,000Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

gene expression analysis
protein expression analysis
cytology specimen collection procedure
laboratory biomarker analysis
physiologic testing
breast duct lavage
endoscopic biopsy
study of high risk factors

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 7, 2004

First Submission Date that Met QC Criteria

Apr 7, 2004

First Posted Date

Apr 8, 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

Jul 22, 2014

Last Update Posted Date

Jul 23, 2014Estimated

Description Module

Brief Summary

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

PURPOSE: This clinical trial is studying how well nipple aspiration, ductal lavage, and breast duct endoscopy work in detecting cancer cells in healthy women who are at moderate-to-high risk of developing breast cancer.

Detailed Description

OBJECTIVES:

Primary

Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of healthy women at moderate to high risk of developing breast cancer, defined by family history or prior atypical biopsy.

Secondary

Correlate cellular atypia with breast cancer, biochemical tumor markers, growth factors, and genetic and protein markers in these participants.
Determine cancer risk and incidence utilizing these methods of screening in these participants.
Observe the natural history of atypia in these participants over a total of 10 years.
Determine whether these techniques may serve as supplementary tools in future screening of these participants.

OUTLINE: Participants under 50 years of age undergo nipple aspiration every twelve months for 3 years. Participants over 50 years of age undergo nipple aspiration every 18 months for 4.5 years.

Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage and endoscopy.

Participants are followed annually for a total of 10 years.

PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study within approximately 4 years.

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

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Significant family history or prior atypical biopsy indicative of a moderate or high risk of developing breast cancer
No concurrent inflammatory breast cancer
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

18 to 64

Sex

Female

Menopausal Status

Premenopausal or postmenopausal

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No prior allergy to EMLA cream or lidocaine
No severe illness that would preclude study participation
No mental illness or handicap that would preclude study compliance
No concurrent active infection or inflammation in the breast being studied
Not unconscious
Not pregnant
No nursing within the past 12 months

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

No prior subareolar surgery (e.g., microdochectomy or major duct excision) that may disrupt the ductal systems within 2 cm of the nipple
No prior breast implantation on proposed lavage side

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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

ID	Term
D020869	Gene Expression Profiling
D000069916	Endoscopic Mucosal Resection

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative
D019060	Minimally Invasive Surgical Procedures

Name	Type	Description	Arm Group Labels	Other Names
gene expression analysis	Genetic
protein expression analysis	Genetic
cytology specimen collection procedure	Other
laboratory biomarker analysis	Other
physiologic testing	Other
breast duct lavage	Procedure
endoscopic biopsy	Procedure

ID	Type	Description	Link
RMNHS-2278
EU-20352