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The Biology of Claudin 3 in Primary Human Mammary Epithelial Cell Culture

This study has been terminated.
(study team failed to complete timely reviews, study suspended)
Sponsor:
Information provided by (Responsible Party):
Hackensack University Medical Center
ClinicalTrials.gov Identifier:
NCT00481585
First received: May 30, 2007
Last updated: February 1, 2014
Last verified: February 2014
  Purpose

The objective of the present study is to determine whether or not primary human mammary epithelial cells are competent for use in molecular studies of transepithelial electrophysiology focusing on the function of the tight junction protein claudin 3.

Human breast Tissue will be removed from mastectomy specimens and used as a source to generate epithelial cells for study.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Biology of Claudin 3 in Primary Human Mammary Epithelial Cell Culture

Resource links provided by NLM:


Further study details as provided by Hackensack University Medical Center:

Primary Outcome Measures:
  • Cell line data study [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: May 2007
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

13 subjects - Subjects of this pilot study are limited to those female patients who are undergoing therapeutic or prophylactic mastectomy procedures conducted by the department of Surgery at HUMC.

Criteria

Inclusion Criteria:

  • Subjects of this pilot study are limited to those female patients who are undergoing therapeutic or prophylactic mastectomy procedures conducted by the department of Surgery at HUMC.

Exclusion Criteria:

  • From within this population, no exclusion criteria shall be applied based on age, race, ethnicity, gender, HIV status, or menopause.
  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: NCT00481585

Locations
United States, New Jersey
Hackensack Univeristy Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack University Medical Center
Investigators
Principal Investigator: Erik F Young, Ph.D. Hackensack University Medical Center
  More Information

No publications provided

Responsible Party: Hackensack University Medical Center
ClinicalTrials.gov Identifier: NCT00481585     History of Changes
Other Study ID Numbers: 07.01.041
Study First Received: May 30, 2007
Last Updated: February 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Hackensack University Medical Center:
claudin
electrophysiology
breast
screening

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

ClinicalTrials.gov processed this record on November 20, 2014