An investigation of proteins found in urine and blood to identify a combination of proteins which will detect bladder cancer

ISRCTN	ISRCTN13449084
DOI	https://doi.org/10.1186/ISRCTN13449084
Protocol serial number	ORECNI 80/04
Sponsor	Belfast City Hospital Trust
Funder	Randox Laboratories Ltd (UK)

Submission date: 30/12/2014
Registration date: 06/02/2015
Last edited: 31/10/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kate Williamson
Scientific

Queen's University Belfast
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

Study information

Primary study design	Observational
Study design	Observational case control study
Secondary study design	Case-control study
Scientific title	Evaluation and comparison of urine markers to investigate the development of a diagnostic index for bladder cancer
Study objectives	A combination of proteins secreted into urine and/or blood will be able to identify patients with bladder cancer
Ethics approval(s)	Office for Research Ethics Committees Northern Ireland (80/04)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	To compare biomarkers as prognostic indicators for TCCB
Completion date	31/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	13/11/2006
Date of final enrolment	22/04/2008

Locations

Countries of recruitment

United Kingdom
Northern Ireland

Study participating centres

Belfast City Hospital

51 Lisburn Road
Belfast
BT9 7AB
United Kingdom

Carigavon Area Hospital

68 Lurgan Road
Portadown
BT63 5QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

31/10/2019: No publications found, verifying study status with principal investigator. The intention to publish date was added.
09/08/2017: No publications found in PubMed, verifying study status with principal investigator.