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A study investigating the use of protein measurements as diagnostic tests for the causes of blood in the urine
ISRCTN ISRCTN25823942
DOI 10.1186/ISRCTN25823942
ClinicalTrials.gov identifier
EudraCT number
Public title A study investigating the use of protein measurements as diagnostic tests for the causes of blood in the urine
Scientific title Haematuria Biomarker Study (HaBio)
Acronym HaBio
Serial number at source N/A
Study hypothesis Collectives of biomarkers aligned with demographics and/or clinical variables can predict bladder cancer in haematuria patients with 90% accuracy.
Lay summary http://www.cancerresearchuk.org/cancer-help/trials/a-study-help-develop-test-find-causes-blood-in-urine-habio
Ethics approval Office of Research Ethics Committee Northern Ireland, 23 December 2012, ref: 11/NI/0164
Study design Case control study
Countries of recruitment United Kingdom
Disease/condition/study domain Haematuria
Participants - 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
Participants - 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
Anticipated start date 17/10/2012
Anticipated end date 28/02/2015
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 999
Interventions 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
Primary outcome measure(s) 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 measure(s) 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
Sources of funding Randox Laboratories Ltd (UK)
Trial website
Publications
Contact name Dr  Kate  Williamson
  Address Queen's University Belfast
Centre for Cancer Research and Cell Biology
97 Lisburn Road
  City/town Belfast
  Zip/Postcode BT9 7BL
  Country United Kingdom
  Tel +44 (0)28 9097 2790
  Fax +44 (0)28 9097 2776
  Email k.williamson@qub.ac.uk
Sponsor Queen’s University Belfast (UK)
  Address c/o Ms Louise Dunlop
Head of Research Governance
Research and Enterprise
Room 114 Lanyon North
  City/town Belfast
  Zip/Postcode BT7 1NN
  Country United Kingdom
  Sponsor website: http://www.qub.ac.uk
Date applied 16/11/2012
Last edited 18/07/2013
Date ISRCTN assigned 03/01/2013
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