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Feasibility Study of Evaluating Breast Cancer Patients With Ductal Lavage

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00156260
First Posted: September 12, 2005
Last Update Posted: October 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Michigan Cancer Center
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00156260     History of Changes
Other Study ID Numbers: UMCC 2-48
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: October 8, 2008
Last Verified: October 2008

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