Feasibility Study of Evaluating Breast Cancer Patients With Ductal Lavage

This study has been terminated.
Sponsor:
Information provided by:
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00156260
First received: September 8, 2005
Last updated: October 4, 2008
Last verified: October 2008
  Purpose

The primary purpose of this research is to analyze the cells present in the fluid obtained via ductal lavage from the nipple of a woman with a known diagnosis of breast cancer. A portion of the lavage fluid may be used in future breast cancer biomarkers. Remaining lavage fluid will be used to analyze its biochemical composition, for investigational purposes only.


Condition Intervention
Breast Cancer
Procedure: Ductal lavage

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: UMCC 2-48 Feasibility Study of Evaluating Breast Cancer Patients With Ductal Lavage

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Estimated Enrollment: 88
Study Start Date: January 2003
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age
  2. biopsy-proven unilateral invasive breast cancer of any histology or ductal carcinoma in situ
  3. patient desires or requires treatment with mastectomy
  4. any patient who has undergone prior excisional biopsy of their primary breast tumor must have had margins positive for disease, or must have either mammographic or ultrasonographic evidence of probable residual disease in the breast.
  5. patients receiving induction chemotherapy remain eligible for participation in the study regardless of tumor response; those with a clinical complete response remain eligible.
  6. voluntarily signed informed consent. -

Exclusion Criteria:

  1. male gender
  2. lobular carcinoma in situ as the only cancerous histology
  3. prior margin-negative excisional biopsy of primary breast tumor, with no evidence of residual disease
  4. patient being treated with breast conservation therapy inability to understand the nature of the procedure pregnancy and/or active lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156260

Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Lisa Newman, M.D. University of Michigan Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00156260     History of Changes
Other Study ID Numbers: UMCC 2-48
Study First Received: September 8, 2005
Last Updated: October 4, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014