Development of a Non-Invasive DNA Methylation-Based Assay System for the Risk Assessment of Urothelial Carcinoma
|ClinicalTrials.gov Identifier: NCT00867620|
Recruitment Status : Unknown
Verified February 2009 by National Taiwan University Hospital.
Recruitment status was: Enrolling by invitation
First Posted : March 24, 2009
Last Update Posted : March 24, 2009
Bladder cancer ranks the ninth in worldwide cancer incidence. Approximate 90% of bladder cancer is the malignancy of urothelium tissues, the urothelial cancer (UC). The mortality of bladder cancer is mainly due to recurrence and metastasis. Unfortunately, the currently available cytology or cystoscopy examination is of limited value because of low sensitivity of early disease. New biomarkers as well as detection technology are thus required to improve early diagnosis. By the aid of quantitative methylation-specific PCR (QMSP), which allows detecting tumor-derived DNA from tissues and body fluids, DNA methylation-based assay is thus developing for early detection and prognosis.
The goal of this proposed project is to develop a panel of DNA-methylation based biomarkers for UC diagnosis, prognosis, and prediction of responses to therapy (especially the recurrence, invasion, survival, and responses to therapeutic agents). Although numerous studies have investigated the aberrant promoter hypermethylation in bladder cancers or UC, inconsistent results are observed. DNA hypermethylation determination may rely on not only the conditions of QMSP, but also the biopsy specimens of different race, environmental expose factors, and regional variation. We thus need to profile the DNA methylation pattern of UC patients in Taiwan to establish a panel of potential prediction biomarkers for local patients.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||82 participants|
|Observational Model:||Case Control|
|Official Title:||Development of a Non-Invasive DNA Methylation-Based Assay System for the Risk Assessment of Urothelial Carcinoma|
|Study Start Date :||August 2008|
|Estimated Study Completion Date :||July 2010|
case group: patients with urothelial carcinoma
control group: those without previous history of any malignancy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867620
|Principal Investigator:||HUNG-YI CHIOU, PhD||COLLEGE OF PUBLIC HEALTH, TAIPEI MEDICAL UNIVERSITY|
|Principal Investigator:||Yeong-Shiau Pu, MD||Department of Urology, National Taiwan University Hospital|
|Principal Investigator:||Te-Chang Lee, PhD||Institute of Biomedical Sciences, Academia Sinica|