Bladder CancerNCT00244205
Identifying Methylation Biomarkers for Monitoring Bladder Tumors
An observational study of Bladder Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
To investigate the methylation status of 4-6 genes in Urine and matching bladder tissue biopsies, in order to find methylation markers for use in a noninvasive test in monitoring patients with bladder tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Identifying genes methylated in urine
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2005to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bladder tumors and patients with benign urinary tract conditions with no clinical suspicion of bladder cancer.
Who cannot join
- Patients with competing urinary and systemic diseases, pregnant and patients under 18 years of age.
Trial locations and contacts
1 site in 1 country.
Jørgen H Andersen contact
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital at Herlev
Herlev, Copenhagen, 2730
Reza R Serizawa, MD, +45 4488 4787 ext. 82607, rerase01@herlevhosp.kbhamt.dk
Reza R Serizawa, MD
About this study
Official title: Using PCR Technology (Polymerase Chain Reaction Technology) for Monitoring Patients With Bladder Tumors - Optimizing Genanalyses for Clinical Use.
To investigate the methylation status of 4-6 genes in Urine and matching bladder tissue biopsies, in order to find methylation markers for use in a noninvasive test in monitoring patients with bladder tumors.
- Conditions
- Bladder Cancer
- Being tested
- Identifying genes methylated in urine
- 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.
Identifying genes methylated in urineProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startNov 2005
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.
- 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
- Prospective
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Investigators
- Reza R Serizawa, MD, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244205
- Sponsor's protocol ID
- Blæretumor PCR projekt
- Status last verified
- Nov 2005
- First submitted
- 24 Oct 2005
- Last updated
- 15 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using PCR Technology (Polymerase Chain Reaction Technology) for Monitoring Patients With Bladder Tumors - Optimizing Genanalyses for Clinical Use.
- ClinicalTrials.gov ID
- NCT00244205
- Acronym / sponsor ID
- Blæretumor PCR projekt
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Nov 2005
- First posted
- 26 Oct 2005 (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.
To investigate the methylation status of 4-6 genes in Urine and matching bladder tissue biopsies, in order to find methylation markers for use in a noninvasive test in monitoring patients with bladder tumors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with bladder tumors and patients with benign urinary tract conditions with no clinical suspicion of bladder cancer.
Key exclusion criteria (1 listed)
- Patients with competing urinary and systemic diseases, pregnant and patients under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identifying genes methylated in urine | Procedure or surgery | – |
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 15 Nov 2005.
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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.
Jørgen H Andersen contact
Reza R Serizawa, MD principal investigator
Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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 15 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Reza R Serizawa, MD (+45 44884787 ext. 82607, rerase01@herlevhosp.kbhamt.dk), or a site near the patient. 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 15 Nov 2005.