- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01378052
DNA Methylation and Urothelial Carcinoma
June 21, 2011 updated by: China Medical University Hospital
Level of DNA Methylation in People With Urothelial Carcinoma
Many studies previously showed the significant association between urinary arsenic profiles and urothelial carcinoma (UC) risk and observed the increased UC risk in people with lower plasma folate and higher homocysteine than those with higher plasma folate and lower homocysteine.
The investigators would expect to explore the interactions among global DNA methylation, one-carbon metabolic pathway factors, urinary arsenic profiles and UC.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chao-Hsiang Chang, PhD
- Phone Number: 4439 886-4-22052121
- Email: urology8395@yahoo.com.tw
Study Locations
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-
404
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Taichung, 404, Taiwan
- Recruiting
- Department of Urology, China Medical University Hospital
-
Contact:
- Chao-Hsiang Chuang, PhD
- Phone Number: 4439 886-4-22052121
- Email: urology8395@yahoo.com.tw
-
-
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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This is a hospital-based case-control study.
Patients with urothelial carcinoma are recruited by pathological verification of UC was done by routine urological practice including endoscopic biopsy or surgical resection of urinary tract tumors followed by histopathological examination by board-certified pathologists.
Healthy controls without evidence of UC or any other malignancy were recruited including those receiving adult health examinations at China Medical University Hospital.
Description
Inclusion Criteria:
- Clinical diagnosis of urothelial carcinoma
- The voluntary of participating the study
Exclusion Criteria:
- Age smaller than 20 years
- Pregnant women
- Not willing to participate the study because of their personal reasons
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
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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urothelial carcinoma pateints
|
healthy controls
Age and gender matched control subjects with no evidence of UC or any other malignancy were accrued from the hospital, recruiting people receiving adult health examinations at China Medical University Hospital.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
urothelial carcinoma
Time Frame: one year
|
Pathological verification of UC was done by routine urological practice including endoscopic biopsy or surgical resection of urinary tract tumors followed by histopathological examination by board-certified pathologists.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chi-Jung Chung, PhD, Department of Health risk Management, China Medical University
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, 2011
Primary Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
June 20, 2011
First Submitted That Met QC Criteria
June 21, 2011
First Posted (Estimate)
June 22, 2011
Study Record Updates
Last Update Posted (Estimate)
June 22, 2011
Last Update Submitted That Met QC Criteria
June 21, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMR100-IRB-092
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.
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Emory UniversityNational Cancer Institute (NCI); ExelixisRecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Unresectable Urothelial Carcinoma | Infiltrating Bladder Urothelial Carcinoma With Squamous DifferentiationUnited States
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Mamta ParikhNational Cancer Institute (NCI); Karyopharm Therapeutics IncRecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Advanced Urothelial Carcinoma | Refractory Urothelial CarcinomaUnited States
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Mayo ClinicNational Cancer Institute (NCI)WithdrawnInfiltrating Bladder Urothelial Carcinoma | Stage II Bladder Urothelial Carcinoma | Stage IV Bladder Urothelial Carcinoma | Stage III Bladder Urothelial CarcinomaUnited States
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