Condition category
Cancer
Date applied
30/12/2014
Date assigned
06/02/2015
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kate Williamson

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Belfast City Hospital Trust

Sponsor details

Lisburn Road
Belfast
BT9 7AD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes