- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00481585
The Biology of Claudin 3 in Primary Human Mammary Epithelial Cell Culture
February 1, 2014 updated by: Hackensack Meridian Health
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Hackensack Univeristy Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cell line data study
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Erik F Young, Ph.D., Hackensack Meridian Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
May 30, 2007
First Submitted That Met QC Criteria
May 30, 2007
First Posted (Estimate)
June 1, 2007
Study Record Updates
Last Update Posted (Estimate)
February 4, 2014
Last Update Submitted That Met QC Criteria
February 1, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 07.01.041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.