Bladder CancerNCT00867620
Development of a Non-Invasive DNA Methylation-Based Assay System for the Risk Assessment of Urothelial Carcinoma
An observational study of Bladder Cancer, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Jul 2010
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- those with histopathological-confirmed urothelial carcinoma will be included.
Who cannot join
- those were younger than 40 years old or with previous history of any other cancers will be excluded.
About this study
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.
Read the detailed description
In the recent years, technologies of genomics, expression analysis and proteomics have been brought to guide the study of risk assessment and early detection of cancers. This proposed study aims to develop a non-invasive DNA methylation-based assay system elucidating a panel of aberrantly hypermethylated genes from urothelial tumors and urine sediments, to improve the risk assessment of urothelial carcinoma; such as early diagnosis, prognosis, and prediction of response to therapeutic regimes. This proposal will establish several techniques to study the methylation status on gene promoter regions. Three tasks will be achieved in this study: (1) Profiling the aberrant DNA methylation in urothelial carcinoma and determining potential prediction biomarkers. (2) Establishing a non-invasive assay by detecting DNA hypermethylation status in exfoliated cells collected from void urine; (3) Mapping the DNA hypermethylation changes from normal to malignant urothelial tumors and studying the underlying mechanism. Through the collaboration of a genetic toxicologist (Te-Chang Lee, PhD, IBMS), a urologist (Yeong-Shiau Pu, MD/PhD, NTUH) and epidemiologists (Hung-Yi Chiou, PhD, Taipei Medical University), we will explore the risk biomarkers for urothelial carcinoma.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | case group: patients with urothelial carcinoma | |
| 2 | control group: those without previous history of any malignancy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startAug 2008
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- HUNG-YI CHIOU, PhD, Principal investigator, COLLEGE OF PUBLIC HEALTH, TAIPEI MEDICAL UNIVERSITYYeong-Shiau Pu, MD, Principal investigator, Department of Urology, National Taiwan University HospitalTe-Chang Lee, PhD, Principal investigator, Institute of Biomedical Sciences, Academia Sinica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867620
- Sponsor's protocol ID
- 200707055R
- Status last verified
- Feb 2009
- First submitted
- 22 Mar 2009
- Last updated
- 24 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Non-Invasive DNA Methylation-Based Assay System for the Risk Assessment of Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT00867620
- Acronym / sponsor ID
- 200707055R
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Study completion
- Jul 2010 (estimated)
- First posted
- 24 Mar 2009 (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.
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.
Detailed description
In the recent years, technologies of genomics, expression analysis and proteomics have been brought to guide the study of risk assessment and early detection of cancers. This proposed study aims to develop a non-invasive DNA methylation-based assay system elucidating a panel of aberrantly hypermethylated genes from urothelial tumors and urine sediments, to improve the risk assessment of urothelial carcinoma; such as early diagnosis, prognosis, and prediction of response to therapeutic regimes. This proposal will establish several techniques to study the methylation status on gene promoter regions. Three tasks will be achieved in this study: (1) Profiling the aberrant DNA methylation in urothelial carcinoma and determining potential prediction biomarkers. (2) Establishing a non-invasive assay by detecting DNA hypermethylation status in exfoliated cells collected from void urine; (3) Mapping the DNA hypermethylation changes from normal to malignant urothelial tumors and studying the underlying mechanism. Through the collaboration of a genetic toxicologist (Te-Chang Lee, PhD, IBMS), a urologist (Yeong-Shiau Pu, MD/PhD, NTUH) and epidemiologists (Hung-Yi Chiou, PhD, Taipei Medical University), we will explore the risk biomarkers for urothelial carcinoma.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –case group: patients with urothelial carcinoma |
| 2 | – | –control group: those without previous history of any malignancy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- those with histopathological-confirmed urothelial carcinoma will be included.
Key exclusion criteria (1 listed)
- those were younger than 40 years old or with previous history of any other cancers will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2009.
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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.
HUNG-YI CHIOU, PhD principal investigator
COLLEGE OF PUBLIC HEALTH, TAIPEI MEDICAL UNIVERSITY
Yeong-Shiau Pu, MD principal investigator
Department of Urology, National Taiwan University Hospital
Te-Chang Lee, PhD principal investigator
Institute of Biomedical Sciences, Academia Sinica
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by National Taiwan University Hospital.
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 24 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 24 Mar 2009.