Bladder CancerPhase 3NCT00553124
Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer
A Phase 3 study testing selenium, vitamin E and biopsy in people with Bladder Cancer, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial summary
RATIONALE: Studying different factors that effect patients with newly diagnosed bladder cancer may help doctors learn more about the disease, improve the ability to plan cancer treatment, and help patients live more comfortably. 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?
- selenium, vitamin E and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 3,400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2005to not given
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma meeting 1 of the following criteria:
- Non-muscle-invasive tumor
- Muscle-invasive tumor
- Solitary G1 pTa tumor
- No previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis
PATIENT CHARACTERISTICS:
- Fit for cystoscopy and surgical biopsy/resection
- No HIV infection
- No condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the study objectives
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH
K. K. Cheng, MD, 44-121-414-6757
About this study
Official title: Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)
RATIONALE: Studying different factors that effect patients with newly diagnosed bladder cancer may help doctors learn more about the disease, improve the ability to plan cancer treatment, and help patients live more comfortably.
PURPOSE: This clinical trial is studying different factors affecting patients with newly diagnosed bladder cancer.
Read the detailed description
OBJECTIVES:
- To assess the effect of lifestyle factors (e.g., smoking, dietary habits, fluid intake, or environmental exposures) on the recurrence and progression of bladder cancer.
- To assess the impact of selenium and/or vitamin E on the progression and recurrence of bladder cancer.
- To study health-related quality of life and its association with recurrence and progression of bladder cancer.
- To establish a bladder cancer tissue bank that will comprise blood, urine, and bladder tissue.
- To study the predictive effect of molecular markers on the recurrence and progression of bladder cancer.
OUTLINE: This is a multicenter study.
The study will be based on a cohort of patients with newly detected bladder cancer in all 16 urological centres within the West Midlands, commencing in late 2005 for a period of 5 years. This research project consists of 5 individual studies: CRUK-BCPP-2005-01-COHORT, CRUK-BCPP-2005-01-MARKERS, CRUK-BCPP-2005-01-QOL, CRUK-BCPP-2005-01-TISSUE-BANK, and CRUK-BCPP-2005-01-TREATMENT. Patients may participate in all or only some of these individual studies.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
- Conditions
- Bladder Cancer
- Being tested
- selenium, vitamin E, biopsy, chemoprevention, cryopreservation
- Keywords
- stage 0 bladder cancer, stage I bladder cancer, stage II bladder cancer, transitional cell carcinoma of the bladder
- 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.
seleniumDrug
vitamin EDrug
biopsyProcedure or surgery
chemopreventionProcedure or surgery
cryopreservationProcedure or surgery
cytology specimen collection procedureProcedure or surgery
diagnostic procedureProcedure or surgery
gene expression analysisProcedure or surgery
immunohistochemistry staining methodProcedure or surgery
laboratory biomarker analysisProcedure or surgery
medical chart reviewProcedure or surgery
mutation analysisProcedure or surgery
polymerase chain reactionProcedure or surgery
quality-of-life assessmentProcedure or surgery
questionnaire administrationProcedure or surgery
study of socioeconomic and demographic variablesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free interval
Progression-free interval
Secondary outcomes (5)
Overall survival time
Incidence of transitional cell carcinoma outside the bladder
Incidence of all other malignancies clinically diagnosed
Incidence of cardiovascular events
Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startDec 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Enrolment
- 3,400 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- K. K. Cheng, MD, Study chair, University Hospital Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553124
- Sponsor's protocol ID
- CDR0000572089
- Other IDs
- CRUK-BCPP-2005-01, ISRCTN13889738, EU-20768
- Status last verified
- Oct 2007
- First submitted
- 2 Nov 2007
- Last updated
- 10 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)
- ClinicalTrials.gov ID
- NCT00553124
- Acronym / sponsor ID
- CDR0000572089
- Conditions
- Bladder Cancer
- Keywords
- stage 0 bladder cancer, stage I bladder cancer, stage II bladder cancer, transitional cell carcinoma of the bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,400 participants
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Study start
- Dec 2005
- First posted
- 5 Nov 2007 (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.
RATIONALE: Studying different factors that effect patients with newly diagnosed bladder cancer may help doctors learn more about the disease, improve the ability to plan cancer treatment, and help patients live more comfortably.
PURPOSE: This clinical trial is studying different factors affecting patients with newly diagnosed bladder cancer.
Detailed description
OBJECTIVES:
- To assess the effect of lifestyle factors (e.g., smoking, dietary habits, fluid intake, or environmental exposures) on the recurrence and progression of bladder cancer.
- To assess the impact of selenium and/or vitamin E on the progression and recurrence of bladder cancer.
- To study health-related quality of life and its association with recurrence and progression of bladder cancer.
- To establish a bladder cancer tissue bank that will comprise blood, urine, and bladder tissue.
- To study the predictive effect of molecular markers on the recurrence and progression of bladder cancer.
OUTLINE: This is a multicenter study.
The study will be based on a cohort of patients with newly detected bladder cancer in all 16 urological centres within the West Midlands, commencing in late 2005 for a period of 5 years. This research project consists of 5 individual studies: CRUK-BCPP-2005-01-COHORT, CRUK-BCPP-2005-01-MARKERS, CRUK-BCPP-2005-01-QOL, CRUK-BCPP-2005-01-TISSUE-BANK, and CRUK-BCPP-2005-01-TREATMENT. Patients may participate in all or only some of these individual studies.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| selenium | Drug | – |
| vitamin E | Drug | – |
| biopsy | Procedure or surgery | – |
| chemoprevention | Procedure or surgery | – |
| cryopreservation | Procedure or surgery | – |
| cytology specimen collection procedure | Procedure or surgery | – |
| diagnostic procedure | Procedure or surgery | – |
| gene expression analysis | Procedure or surgery | – |
| immunohistochemistry staining method | Procedure or surgery | – |
| laboratory biomarker analysis | Procedure or surgery | – |
| medical chart review | Procedure or surgery | – |
| mutation analysis | Procedure or surgery | – |
| polymerase chain reaction | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
| questionnaire administration | Procedure or surgery | – |
| study of socioeconomic and demographic variables | Procedure or surgery | – |
Primary outcome
Recurrence-free interval
Progression-free interval
5 secondary outcomes
Overall survival time
Incidence of transitional cell carcinoma outside the bladder
Incidence of all other malignancies clinically diagnosed
Incidence of cardiovascular events
Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 questionnaires
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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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.
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, United Kingdom
K. K. Cheng, MD study chair
University Hospital Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing selenium, vitamin E and biopsy in people with Bladder Cancer, run by University Hospital Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Jan 2014. 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 United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free interval. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 10 Jan 2014.