Condition category
Signs and Symptoms
Date applied
16/11/2012
Date assigned
03/01/2013
Last edited
18/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Kate Williamson

ORCID ID

Contact details

Queen's University Belfast
Centre for Cancer Research and Cell Biology
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom
+44 (0)28 9097 2790
k.williamson@qub.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Haematuria Biomarker Study (HaBio)

Acronym

HaBio

Study hypothesis

Collectives of biomarkers aligned with demographics and/or clinical variables can predict bladder cancer in haematuria patients with 90% accuracy.

Ethics approval

Office of Research Ethics Committee Northern Ireland, 23 December 2012, ref: 11/NI/0164

Study design

Case control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Haematuria

Intervention

At the clinic the Research Nurse will record height, weight and blood pressure, medical history and ask questions about lifestyle and occupations before collecting one urine and one blood sample. The first 20 patients in this part of the study will be asked to provide approximately 25ml urine sample (approximately 5 teaspoons), and a 45ml blood sample (9 teaspoons). All patients after this will be asked to provide approximately 25ml sample of urine (5 teaspoons) and approximately 35ml sample of blood (7 teaspoons). If diagnosis is confirmed using bladder tissue removed during the surgical procedure the researchers will review the tissue and use small samples to identify protein and other constituents including DNA and RNA within the tissue structures. The patient’s notes will be reviewed by members of the HaBio clinical team. The HaBio clinical team will inform the patient’s consultant of their review findings should this be appropriate. This will be beneficial for patients. Members of the HaBio clinical team will review the patient’s notes for a second time 3 years after recruitment to obtain updated information about the patient’s health.

Joint / Secondary sponsor details:
Ms Alison Murphy (Research Manager)
Belfast Health and Social Care Trust
Lisburn Road
Belfast
BT9 7AD

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. To define individual sensitivities and specificities for all key biomarkers based on data from ~999 patients presenting with haematuria
2. To create a diagnostic algorithm based on demographics, lifestyle, medications and smoking to act as a bench mark for the diagnostic algorithms
3. To create diagnostic algorithms combining individual biomarker data as appropriate
4. To define sensitivities and specificities for diagnostic algorithm(s)
5. To create a biochip(s) formatted with the protein biomarkers which contribute to the algorithm(s)
6. To optimise the biochip(s)
7. To gain understanding of the underlying pathobiology of bladder carcinogenesis using both classical statistics and novel statistical approaches to analyse the extensive database that will be generated

Secondary outcome measures

1. To create algorithms which differentiate between benign causes of haematuria patients such as BPE, stones, kidney disease and inflammatory disease (these algorithms may require validation is a separate future study)
2. To create algorithms which differentiate “high” and “low” risk sub-populations
3. To determine levels, patterns of expression and cell type location of key biomarkers using appropriate immunohistochemistry (IHC) on sections from Tissue Microarrays obtained under the auspices of the Northern Ireland BioBank.
4. Determine the association between grade, stage and inflammation and the presence/absence of key biomarker immunoreactivity
5. To determine the association between measured biomarker levels in urine or serum and intensity of immunoreactivity in tumour samples

Overall trial start date

17/10/2012

Overall trial end date

28/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Bladder cancer patients
Patients with pathologically proven bladder cancer, newly diagnosed or recurrent, will be recruited prior to transurethral resection of the bladder tumour at pre-assessment clinics, as in-patients on urology wards or at planned cystoscopy sessions.
1. Written informed consent to participate in the study
2. Aged between 40 and 80 years
3. Current haematuria or a history of haematuria
4. Cystoscopy within the last 6 months or planned cystoscopy
5. No chemo- or radio- therapy in the three weeks prior to recruitment
6. No previous history of cancers other than bladder cancer
7. Suspicion of bladder cancer or proven bladder cancer

Control patients
These patients will be recruited from haematuria clinics following negative cystoscopy and negative findings for other bladder cancer investigations.
1. Written informed consent to participate in the study
2. No previous history of cancer
3. Of the same gender, approximate age and smoking status (where possible) to a bladder cancer patient already recruited to HaBio
4. Current haematuria or a history of haematuria
5. Negative cystoscopy within the last 3 months, but at least 48h after the procedure
6. No chemo- or radio- therapy in the three weeks prior to recruitment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

999

Participant exclusion criteria

Bladder cancer patients:
1. No written informed consent to participate in the study
2. Aged < 40 or > 85 years
3. No history of haematuria
4. No recent or planned cystoscopy
5. Chemo- or radio- therapy in the three weeks prior to recruitment
6. Previous history of cancer(s), other than bladder cancer
7. No suspicion of bladder cancer or proven bladder cancer

Control patients:
1. No written informed consent to participate in the study
2. Previous history of any cancer
3. Not of the same gender, approximate age and smoking status of a patients already recruited as a bladder cancer patient
4. No history of haematuria
5. No recent or planned cystoscopy
6. Chemo- or radio- therapy in the three weeks prior to recruitment

Recruitment start date

17/10/2012

Recruitment end date

28/02/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen's University Belfast
Belfast
BT9 7BL
United Kingdom

Sponsor information

Organisation

Queen’s University Belfast (UK)

Sponsor details

c/o Ms Louise Dunlop
Head of Research Governance
Research and Enterprise
Room 114 Lanyon North
Belfast
BT7 1NN
United Kingdom

Sponsor type

University/education

Website

http://www.qub.ac.uk

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes