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DNA Methylation and Urothelial Carcinoma

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ClinicalTrials.gov Identifier: NCT01378052
Recruitment Status : Unknown
Verified June 2011 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : June 22, 2011
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:
China Medical University Hospital

Brief Summary:
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.

Condition or disease
Urothelial Carcinoma

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Level of DNA Methylation in People With Urothelial Carcinoma
Study Start Date : June 2011
Estimated Primary Completion Date : June 2012

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378052


Contacts
Contact: Chao-Hsiang Chang, PhD 886-4-22052121 ext 4439 urology8395@yahoo.com.tw

Locations
Taiwan
Department of Urology, China Medical University Hospital Recruiting
Taichung, 404, Taiwan
Contact: Chao-Hsiang Chuang, PhD    886-4-22052121 ext 4439    urology8395@yahoo.com.tw   
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Chi-Jung Chung, PhD Department of Health risk Management, China Medical University

Responsible Party: Chao-Hsiang Chang, Department of Urology
ClinicalTrials.gov Identifier: NCT01378052     History of Changes
Other Study ID Numbers: DMR100-IRB-092
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms