Bowen DiseaseNCT00166946
Effects of Arsenic on Keratinocytes in a Skin Equivalent Model
A study testing foreskin from healthy adults for organotypic culture in people with Bowen Disease, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
We popose that arsenic-induced lymphocytes dysfunction plays an important role in biological mechanisms of arsenical Bowen's disease. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bowen Disease
- What is being tested?
- foreskin from healthy adults for organotypic culture
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jun 2005to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy adult -
Who cannot join
- systemic disease or with a history of exposure to arsenic-
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 1 recruiting
- Suspended
National Taiwan University Hospital
Taipei, Taiwan, Province of China, 100
- Recruiting
National Taiwan University Hospital
Taipei, 100
Hsin-Su Yu, MD PHD, 886-2-23562141, dermyu@ha.mc.ntu.edu.tw
About this study
We popose that arsenic-induced lymphocytes dysfunction plays an important role in biological mechanisms of arsenical Bowen's disease.
Read the 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.
- Conditions
- Bowen Disease
- Being tested
- foreskin from healthy adults for organotypic culture
- Medical subject headings
- Bowen's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foreskin from healthy adults for organotypic cultureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
we collect foreskin from healthy adults
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowen DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hsin-Su Yu, MD PHD, Study director, National Taiwan Univesity Hospital, Dept. of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166946
- Sponsor's protocol ID
- 9361701179
- Status last verified
- Nov 2004
- First submitted
- 12 Sep 2005
- Last updated
- 21 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Arsenic on Keratinocytes in a Skin Equivalent Model
- ClinicalTrials.gov ID
- NCT00166946
- Acronym / sponsor ID
- 9361701179
- Conditions
- Bowen Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jan 2008
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We popose that arsenic-induced lymphocytes dysfunction plays an important role in biological mechanisms of arsenical Bowen's disease.
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 design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal healthy adult -
Key exclusion criteria (1 listed)
- systemic disease or with a history of exposure to arsenic-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| foreskin from healthy adults for organotypic culture | Procedure or surgery | – |
Primary outcome
we collect foreskin from healthy adults
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsin-Su Yu, MD PHD study director
National Taiwan Univesity Hospital, Dept. of Dermatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foreskin from healthy adults for organotypic culture in people with Bowen Disease, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsin-Su Yu, MD PHD (886-2-23562141, dermyu@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
we collect foreskin from healthy adults. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2005.