Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ORECNI 80/04
Study information
Scientific title
Evaluation and comparison of urine markers to investigate the development of a diagnostic index for bladder cancer
Acronym
Study hypothesis
A combination of proteins secreted into urine and/or blood will be able to identify patients with bladder cancer
Ethics approval
Office for Research Ethics Committees Northern Ireland (80/04)
Study design
Observational case control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Haematuria in bladder cancer
Intervention
This study recruited 200 patients who had reported blood in their urine to their doctor. Half of these patients had a final diagnosis of bladder cancer and the other half had other diagnoses. Blood and urine was taken from each patient. The levels of different proteins in the urine and blood were measured on anonymised blood and urine samples by a company called Randox Laboratories Ltd.
Intervention type
Other
Phase
Drug names
Primary outcome measures
1. To compare specificities and sensitivities of the TCCB markers and generic cancer markers in predicting TCCB
3. To retain a bank of urine and blood samples if the need arise to assay further markers
4. To determine the best combination of factors for a prognostic index for TCCB
Secondary outcome measures
To compare biomarkers as prognostic indicators for TCCB
Overall trial start date
01/09/2004
Overall trial end date
31/10/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with haematuria who have undergone cystoscopy
2. Patients must be able to understand the study procedures and willing to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Patients who have not had a flexible cytoscopy
2. Patients who did not present with haematuria
3. Patients with UTI destined to undergo TURB
4. Patients currently suffering from clinically evident alcoholism and or drug dependency
Recruitment start date
13/11/2006
Recruitment end date
22/04/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Belfast City Hospital
51 Lisburn Road
Belfast
BT9 7AB
United Kingdom
Trial participating centre
Carigavon Area Hospital
68 Lurgan Road
Portadown
BT63 5QQ
United Kingdom
Funders
Funder type
Industry
Funder name
Randox Laboratories Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary