Development of a Non-Invasive DNA Methylation-Based Assay System for the Risk Assessment of Urothelial Carcinoma

NCT00867620 | Unknown DMC

• 1 other identifier: 200707055R
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bladder Cancer

Study Arms (2)

1

case group: patients with urothelial carcinoma

2

control group: those without previous history of any malignancy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects from the Department of Urology of NTUH. Those with urothelial carcinoma(bladder, renal pelvis and ureter) will be recruited in this study period. After they signed the informed consent,we will ask them some questions through face-to-face interview and collect 6-8ml blood and 50c.c. urine. Then genomic DNA will be extracted from these biospecimens to perform a non-invasive DNA methylation-based assay.

You may qualify if:

• those with histopathological-confirmed urothelial carcinoma will be included.

You may not qualify if:

• those were younger than 40 years old or with previous history of any other cancers will be excluded.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

These biospecimens will be keep in low-temperature (-80 degree)and then genomic DNA will be extracted from blood/urine samples until the detection of DNA methylation profiles.

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 22, 2009
• First Posted: March 24, 2009
• Study Start: August 1, 2008
• Study Completion: July 1, 2010
• Last Updated: March 24, 2009

Record last verified: 2009-02