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
Secondary identifying numbers	ORECNI 80/04

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

Study design	Observational case control study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Diagnostic
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	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 study start date	01/09/2004
Completion date	31/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Northern Ireland
United Kingdom

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

Sponsor information

Belfast City Hospital Trust
Hospital/treatment centre

Lisburn Road
Belfast
BT9 7AD
Northern Ireland
United Kingdom

"ROR"	https://ror.org/02405mj67

Funders

Funder type

Industry

Randox Laboratories Ltd (UK)

No information available

Results and Publications

Intention to publish date	01/01/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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.