Condition category
Signs and Symptoms
Date applied
16/11/2012
Date assigned
03/01/2013
Last edited
06/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer 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 28 9097 2790
k.williamson@qub.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A study investigating the use of protein measurements as diagnostic tests for the causes of blood in the urine

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, 23/12/2012, 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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Single biomarkers and/or multivariate algorithms will significantly improve on the predictive power of an algorithm based on demographics for prediction of causes of haematuria in patients presenting with haematuria.

Secondary outcome measures

1. Patient age, gender, current medications, date of cystoscopy and date of initial diagnosis of bladder cancer (if relevant) are recorded from the patient notes by a Clinical Research Nurse (CRN) or the HaBio clinician at the time of recruitment
2. Blood pressure and body mass index (BMI) measurements, together with dip-stick analyses are undertaken by the CRN or the HaBio clinician at the time of recruitment
3. A detailed history of smoking, cancers, hypertension, renal stones, pelvic irradiation, and urinary tract infections; weekly alcohol consumption; present and past occupations; lower urinary symptoms; and whether the patient presented with visible or non-visible haematuria are recorded by the CRN or the HaBio clinician following discussion with each patient at their time of recruitment
4. Urine and blood samples are obtained from each patient by the CRN or the HaBio clinician at the time of recruitment
5. Scientists complete analyses of ~ 60 biomarker levels for each patient at Randox Laboratories Ltd (Country Antrim, Northern Ireland) as soon as possible after recruitment
6. Investigation results, details of positive micro-organism findings, causes of infection, causes of benign disease and levels of clinical biomarkers are recorded following review of the patient notes by a consultant urologist at least six weeks after recruitment
7. One or more causes of haematuria are recorded for each patient following review of the patient notes by a consultant urologist at least six weeks after recruitment
8. Where applicable, cause of death, details of chronic kidney disease, non-urological cancers, biomarkers measured in NHS, bladder cancer treatments, prostate and kidney pathology are recorded following review of the patient notes by the HaBio Clinician at the time of follow up
9. Where applicable, pathological review to obtain dates of recurrences and progression and pathology reports for tissue removed at the time of recruitment are recorded for all patients following review of the patient notes by the HaBio Clinician at the time of follow up
10. A detailed pathological review including details of pathological variants is completed by a consultant pathologist following completion of follow up
11. Patterns of expression and cell type location of key biomarkers using appropriate immunohistochemistry (IHC) on sections from diagnostic bladder tissue samples from patients is completed for each patient after completion of the diagnostic review by a Consultant Pathologist

Overall trial start date

17/10/2012

Overall trial end date

31/12/2017

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

27/11/2012

Recruitment end date

28/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Belfast City Hospital
Department of Urology Lisburn Road
Belfast
BT9 7AB
United Kingdom

Trial participating centre

Ulster Hospital Dundonald
Upper Newtownards Road
Dundonald
B16 1RH
United Kingdom

Trial participating centre

Craigavon Hospital
68 Lurgan Road
Portadown
B63 5QQ
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

HaBio is the follow-on study from a trial published, following peer-review, in Cancer in 2012 (https://www.ncbi.nlm.nih.gov/pubmed/21918968) which described the feasibility of producing diagnostic algorithms for bladder cancer in patients presenting with haematuria. One publication will present the HaBio findings in a similar fashion. There are plans to submit this manuscript to a high impact journal in the Autumn 2017. Another manuscript on the cost effectiveness of a diagnostic classifier for risk stratification of haematuria patients (DCRSHP) compared to flexible cystoscopy in the diagnosis of bladder cancer is also being prepared, as well as plans to submit data on risk stratification to the NCRI Conference that will take place in Liverpool in November 2017.

IPD sharing statement:
The datasets generated during and/or analysed during the current study may be available for research collaborations (k.williamson@qub.ac.uk)

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/06/2017: The outcome measures have been updated to include timepoints and methods of measurement. 05/06/2017: The following changes have been made to the record: 1. The overall trial dates have been updated from 17/10/2012 - 28/02/2015 to 17/10/2012 - 31/12/2017 2. The receruitment dates have been updated from 17/10/2012 - 28/02/2015 to 27/11/2012 - 28/06/2017 3. The trial participating centres, publication and dissemination plan and IPD sharing plan have been added 17/01/2017: No publications found in PubMed, verifying study status with principal investigator.