Bladder cancer Cancer Malignant neoplasm of bladder
Conditions
Interventions
Current intervention as of 15/07/2022:
This study aims to assess the feasibility of urine self-testing as an early detection method for bladder cancer. The study will also collect data to help design
Sponsors
University of Sheffield
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Inclusion criteria
Inclusion criteria: Cohort 1: 1. Men and women 2. Aged 55 – 80 years 3. Participants already enrolled within the YLST 4. Registered with a GP within the Leeds CCG area 5. Consented to contact from other research teams at the second YLST Lung Health Check visit Cohort 2: 1. Men aged 65-79 years 2. Registered with a GP Practice identified as being in a region with a high bladder cancer mortality risk Cohort 3: 1. Men and women aged 65-79 years referred to a recruiting urological department under the 2WW pathway for the investigation of haematuria (to include cystoscopy and urinary tract ultrasound, ± CT urogram)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 15/07/2022: Cohort 1: 1. Unable to/did not consent to contact from other research teams 2. Insufficient capacity to give consent to take part in the research as determined by the investigator/person taking consent for those that attend an Early Detection Clinic appointment. Cohort 2: 1. National Data Opt-outs 2. Ever diagnosis of bladder or kidney cancer 3. Diagnosis with any other cancer within the past 5 years (except non-malignant skin cancer) 4. Insufficient capacity to give consent to take part in the research, defined as the presence of the following conditions coded in GP records: 4.1. Dementia 4.2. Alzheimer’s disease 4.3. Parkinson’s disease or as determined by the investigator/person taking consent for those that attend an Early Detection Clinic appointment Cohort 3: 1. Unable to provide written informed consent 2. Insufficient capacity to give consent to take part in the research, defined as the presence of the following conditions in medical notes: 2.1. Dementia 2.2. Alzheimer’s disease 2.3. Parkinson’s disease or as determined by the investigator/person taking consent at the 2WW appointment 3. Evidence in patient medical record of historic dissent to use of data in research 4. Participant has opted out of data use via the National Data Opt Out Previous exclusion criteria: Cohort 1: 1. Unable to/did not consent to contact from other research teams 2. Insufficient capacity to give consent to take part in the research as determined by the investigator/person taking consent for those that attend an Early Detection Clinic appointment. Cohort 2: 1. National Data Opt-outs 2. Ever diagnosis of bladder or kidney cancer 3. Diagnosis with any other cancer within the past 5 years (except non-malignant skin cancer) 4. Insufficient capacity to give consent to take part in the research, defined as the presence of the following conditions coded in GP records: 4.1. Dementia 4.2. Alzheimer’s disease 4.3. Parkinson’s disease or as determined by the investigator/person taking consent for those that attend an Early Detection Clinic appointment Cohort 3: 1. Unable to provide written informed consent 2. Insufficient capacity to give consent to take part in the research, defined as the presence of the following conditions in medical notes: 2.1. Dementia 2.2. Alzheimer’s disease 2.3. Parkinson’s disease or as determined by the investigator/person taking consent at the 2WW appointment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 15/07/2022: As this is a feasibility study there are multiple primary outcomes which will all be assessed at the end of the trial: 1. Acceptability of urine self-testing and Early Detection Clinic procedures will be measured via: 1.1. The proportion of invitees who report results for at least 1 test strip 1.2. The proportion of participants who attend and consent for cytology and urinary tract ultrasound following detection of haematuria on self-testing 1.3. Proportions of participants who attend and consent for HbA1c blood testing following the detection of glycosuria on self-testing. 2. Compliance with urine self-testing will be measured via: 2.1. The proportion of participants who report results for i) all 6 test strips, and ii) 3 or more test strips 2.2. The number of test strips returned on average in those who return at least one test strip 3. Haematuria in the population will be measured via the proportions of haematuria in participants (=1 test strip positive for haematuria) 4. Glycosuria in the population will be measured via the proportions of glycosuria in participants (=1 test strip positive for glycosuria) 5. Haematuria clinic outcomes will be measured via: 5.1. The proportion of positive or abnormal cytology in those where a urine sample is collected 5.2. The proportion of participants scanned who have an abnormal ultrasound scan 6. Glycosuria clinic outcomes will be measured via the proportions of those with an elevated HbA1c following collection of a blood sample 7. Urinary symptoms will be measured via symptom scores from the urine symptoms questionnaire (as completed prior to self-testing) 8. Bladder cancer in the tested population will be measured via the proportions of bladder cancer and corresponding stage in identified participants (excluding non-responders and withdrawals) 9. The accuracy of self-testing, cytology, and ultrasound scan will be measured via: 9.1. The sensitivity, specificity, | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/07/2022: 1. Reporting of self-test results via mobile app or freephone will be measured by the proportions of app or phone line use, and the impact on sensitivity and specificity to detection of cancer at the end of the trial 2. The acceptability of the reciprocal design will be measured by the proportions of compliance/attendance/surveys at the end of the trial Exploratory outcome measures: 1. Comparison of populations, demographics and cancer incidence of those who complete self-testing and those who do not will be measured by comparing the characteristics of participants who are invited to take part to those not invited to take part (to compare characteristics where available including sex, age group, quintile of deprivation, smoking history). All participants that self-test will be flagged in NCRAS for cancer diagnoses at 1, 2 and 3 years following the end of the trial. 2. The development of an artificial intelligence (AI) platform for the assessment of urine samples for cytology analysis for the future study will be measured by the accuracy of the AI read versus the manual read at the end of the trial. 3. The potential harm of cystoscopy adverse effects, specifically urinary tract infections requiring medical treatment, will be measured by the proportions of participants that have a UTI requiring medical treatment following cystoscopy at the end of the trial. 4. The development of a health economics model using the information from this feasibility study that could be used to develop a future community-based screening programme for bladder cancer will be measured at the end of the study by: 4.1. Resource usage in each arm (number of clinics used, blood tests, ultrasound tests, extra NHS tests) 4.2. Rate of cancers and other illnesses per arm 5. The addition of other urinary contents (leukocytes, nitrate, protein) in relation to the risk prediction of bladder cancer will be measured by other positive test strip panels | — |
Countries
England, United Kingdom
Contacts
Public ContactAbigail Carter
Outcome results
None listed