Foreskin from healthy adults for organotypic culture in Bowen Disease - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Bowen Disease

Intervention / Treatment

Procedure: foreskin from healthy adults for organotypic culture

Detailed Description

Arsenical cancers (comprising skin, bladder, kidney, lung, colon and liver malignancies) were prevalent in southwestern coast of Taiwan where the artesian water was contaminated with high concentration of arsenic. Skin is a main target of arsenical poisoning. The cutaneous manifestations of chronic arsenism can take form as hyperpigmentation, hypopigmentation, arsenical keratosis and arsenical skin cancers. The most popular arsenical skin cancer is Bowen's disease, which is a carcinoma in situ of skin and often confined to sun-protected skin. Pathologically, there are several characteristics present in Bowen's disease: (1) abnormal cell proliferation and carcinogenesis in keratinocytes; (2) dysplasia and apoptosis at the lesion; (3) integrin deficiency/defect in the basal cells of the skin; (4) dysfunctions in peripheral immune cells. Our pervious results indicated that arsenic affected cell cycle regulation by influencing the proliferation and apoptosis of keratinocytes. Furthermore, we found that integrins were deficient in basal layer of lesional and perilesional sites of Bowen's disease as demonstrated by immunohistochemistry. The integrin deficiency in Bowen's disease might lead to abnormality of cell cycle regulation, differentiation and carcinogenesis. In addition, arsenic can destruct lymphocytes to cytokine regulation and induce lymphocytes apoptosis. We propose that arsenic-induced lymphocytes dysfunction plays an important role in biological mechanisms of arsenical Bowen's disease. There are many regulatory mechanisms involved in progression of chemical carcinogenesis, including the reactions among carcinogen and target cells, supporting cells and immune interactions. Therefore, this study is to investigate these skin cell-cell interactions induced by arsenic using an organotypic epidermis culture model. By using this model, we can mimic the mechanism of arsenic-induced skin diseases. Which will give us much more information that similar to carcinogenesis progesee in human body as compared to cell culture model. The effects of arsenic on epidermis formation, the effects of UVB and arsenic on arsenical carcinogenesis and the interactions between immune cells and skin cells will be studied in this 3-year proposal as described below:

The 1st year: Study of arsenical effects on integrin expression, cell proliferation, differentiation and apoptosis in organotypic epidermis.

The 2nd year: Study of arsenic and/or UVB -induced biological changes in organotypic epidermis and Bowen's disease.

The 3rd year: Study of the interactions between immune cells and epidermal cells induced by arsenic.

This study will give us much more information that similar to carcinogenesis progesee in human body as compaired to cell culture model. We hope the result of this study can provide a useful model in chemical carcinogenesis investigation field.

Study Type

Interventional

Enrollment

20

Phase

Not Applicable

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

Taiwan
- - Taipei, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital
    - Contact:
      
      Hsin-Su Yu, MD PHD
      
      Phone Number: 886-2-23562141
      
      Email: dermyu@ha.mc.ntu.edu.tw
- Taiwan, Province of China
  - Taipei, Taiwan, Province of China, Taiwan, 100
    - Suspended
    - National Taiwan University Hospital

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

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Normal healthy adult -

Exclusion Criteria:

systemic disease or with a history of exposure to arsenic-

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

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
we collect foreskin from healthy adults

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

Study Director: Hsin-Su Yu, MD PHD, National Taiwan Univesity Hospital, Dept. of Dermatology

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

June 1, 2005

Study Completion

January 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria