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Status:

COMPLETED

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

Lead Sponsor:

Royal Marsden NHS Foundation Trust

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-64 years

Phase:

NA

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. PURPOS...

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 hist...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    1000 Patients enrolled

    Trial Details

    Trial ID

    NCT00081003

    Start Date

    November 1 2003

    Last Update

    July 23 2014

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Royal Marsden - London

    London, England, United Kingdom, SW3 6JJ