Haematuria Biomarker Study (HaBio)
| ISRCTN | ISRCTN25823942 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25823942 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/11/2012
- Registration date
- 03/01/2013
- Last edited
- 31/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Dr Kate Williamson
Scientific
Scientific
Queen's University Belfast
Centre for Cancer Research and Cell Biology
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom
| Phone | +44 28 9097 2790 |
|---|---|
| kate.williamson749@gmail.com |
Study information
| Study design | Case control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A study investigating the use of protein measurements as diagnostic tests for the causes of blood in the urine |
| Study 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(s) | Office of Research Ethics Committee Northern Ireland, 23/12/2012, ref: 11/NI/0164 |
| 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 patients notes will be reviewed by members of the HaBio clinical team. The HaBio clinical team will inform the patients consultant of their review findings should this be appropriate. This will be beneficial for patients. Members of the HaBio clinical team will review the patients notes for a second time 3 years after recruitment to obtain updated information about the patients health. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 17/10/2012 |
| Overall study end date | 21/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 999 |
| Total final enrolment | 677 |
| 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 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
- England
- Northern Ireland
- United Kingdom
Study participating centres
Belfast City Hospital
Department of Urology
Lisburn Road
Belfast
BT9 7AB
United Kingdom
Lisburn Road
Belfast
BT9 7AB
United Kingdom
Ulster Hospital Dundonald
Upper Newtownards Road
Dundonald
B16 1RH
United Kingdom
Dundonald
B16 1RH
United Kingdom
Craigavon Hospital
68 Lurgan Road
Portadown
B63 5QQ
United Kingdom
Portadown
B63 5QQ
United Kingdom
Sponsor information
Queens University Belfast (UK)
University/education
University/education
c/o Ms Louise Dunlop
Head of Research Governance
Research and Enterprise
Room 114 Lanyon North
Belfast
BT7 1NN
Northern Ireland
United Kingdom
| Website | http://www.qub.ac.uk |
|---|---|
"ROR" |
https://ror.org/00hswnk62 |
Funders
Funder type
Industry
Randox Laboratories Ltd (UK)
No information available
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication and dissemination plan, as of 12/04/2021: We are currently preparing the following manuscripts which will i) describe adherence to STARD guidelines and the characteristics of the patients ii) present our findings about the impact of smoking on bladder carcinogenesis in the HaBio cohort iii) will discuss our interpretation of the biomarker data in the context of risk stratification of patients presenting with haematuria in a Northern Ireland population iv) will report on the characteristics of the diabetic sub-populations within the HaBio cohort Further manuscripts will be written to describe findings from our Tissue Microarray studies. Publication and dissemination plan as of 19/12/2018: We plan to submit five manuscripts based on the HaBio data, during the Spring/Summer of 2019. One manuscript will report on smoking and occupational carcinogen exposure in the development of bladder cancer in a Northern Ireland population. A second paper will focus on the causes of haematuria. A third manuscript will report on the characteristics of the diabetic sub-populations within the HaBio cohort. Further manuscripts will be written to describe findings from our Tissue Microarray studies. Previous 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 plan | The datasets generated during and/or analysed during the current study may be available for research collaborations (k.williamson@qub.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2022 | 31/10/2022 | Yes | No |
Editorial Notes
31/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
26/08/2022: The contact email was updated.
12/04/2021: The following changes were made to the trial record:
1. The publication and dissemination plan, was updated.
2. The intention to publish date was changed from 30/05/2019 to 01/01/2022.
09/06/2020: The overall trial end date was changed from 30/06/2019 to 21/02/2020.
19/12/2018: The following changes were made to the trial record:
1. The publication and dissemination plan was updated.
2. The intention to publish date was changed from 31/12/2017 to 30/05/2019.
13/12/2018: The overall trial end date was updated from 31/12/2017 to 30/06/2019.
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 recruitment 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 the principal investigator.
