IDENTIFY Overview

Background

Data from the IDENTIFY study has provided a predictive model to predict the risk of urinary tract cancer (bladder, renal and upper tract urothelial cancer) in patients referred to secondary care with haematuria, and without a previous history of urological malignancy.

The risk calculator from the predictive model can be found online here and on Apple and Android devices as an app called “IDENTIFY Risk Calculator”.

Study Design

Prospective multicentre international study to validate the IDENTIFY risk calculator

Patients

Inclusion Criteria:

1. Any patient aged 16 and over, with haematuria (visible or nonvisible) undergoing cystoscopy and investigation for urinary tract cancer.

Exclusion Criteria:

1. Patients with a previous or known diagnosis of primary upper or lower urinary tract cancers (renal, ureteric, bladder, prostate, urethral and penile cancers). This includes patients with suspected recurrence of urothelial cancers.

2. Patients undergoing cystoscopy for reasons unrelated to ruling out urothelial cancer.

Objectives

Primary Objective:

1. External validation of the IDENTIFY risk calculator

Secondary Objective:

1. Prevalence of urothelial cancer in patients referred to secondary care with haematuria.

Outcomes

Primary Outcomes:

1. Area under the receiver operating characteristic curve (AUC) for the detection of urinary tract cancer

2. Calibration coefficient and intercept

Secondary Outcomes:

1. Prevalence of individual patient characteristics/variables used in the risk calculator.

2. Prevalence of urinary tract cancers overall and individually (bladder, renal and upper tract urothelial cancer) in the validation cohort

Methods

Patient data should be collected from secondary care centres that evaluate patients with suspected haematuria and have the ability for cystoscopy (flexible or rigid) to be carried out and trans-urethral resection of bladder tumours to be performed.

Trainees, speciality doctors, consultants, nurses or equivalent that perform, assist or have access to cystoscopy lists are ideally suited to take part as collaborators. Participating collaborators are required to register their site with the permission of a local consultant urologist. Participating collaborators will complete a data collection tool of prospective patients referred to the centre for cystoscopy +/- imaging tests to rule out urinary tract cancer. Collaborators should ideally collect data as they see each patient in the cystoscopy clinic but this can be done immediately after a clinic if all of the data required is collected in the patient notes. All data collected is data that is routinely collected as part of haematuria assessments. Patients with suspected cancer findings undergoing further investigations or surgery (e.g. TURBT) should be followed up and the histopathology for these investigations and procedures should be collected. Patients found to have cancer should be followed up until pathology is available (if applicable). It is not anticipated that follow up for any specific patient will exceed 3 months.

Data will be entered directly onto a Redcap database. Only anonymised data will be collected. Caldicott principles will be followed.

Data to be Collected:

1. IDENTIFY risk calculator variables

2. Presence and type of cancer

3. Histopathological grade and staging

Quality control:

All data will be checked prospectively to ensure good quality data entry and complete records. Sites will be contacted to fill in missing data for mandatory fields.

Sample Size

The unadjusted prevalence of urinary tract cancer from the IDENTIFY study was 20.7%. On the basis of requiring 20 events per variable, with 13 variables, we would require a sample size of approximately 1250 patients.

We would expect each collaborator to collect data from at least 15 patients and so would require approximately 100 collaborators.

Timeline

- January 2022 - March 2022: Registration

- February 2022 - May 2022: Collect Data

- May 2022 - June 2022: Data analysis

- July 2022: Submission to journal

To qualify for collaborative authorship:

1. We would expect each collaborator to collect data from at least 15 patients and so would require approximately 100 collaborators.

It is intended that all people collecting data that meet the minimum site requirements, as specified in advance, would be recognised as PubMed Indexed collaborators. It is acknowledged that the specific format and display of this recognition is subject to specific requirements of the journal that we submit to. We will acknowledge all collaborators as part of the “IDENTIFY study group” on papers and in presentations of work. Evidence of contribution to the work will also be provided on the BURST website

People who are the top recruiters to the study will be invited to the writing group, main authorship line, and will be given preference for national and international scientific presentations of the work as well as for further work relating to this project. Specialist advisors and peer reviewers will be specifically acknowledged for their role.

Ethics and local governance:

This project qualifies as a service evaluation as per HRA UK guidelines, and the data to be collected is non-identifiable. This will mean it is exempt from ethical approval.Each participating site will get audit department / R&D ethics exemption in writing and will send registration numbers, where applicable, to the IDENTIFY team. For international sites, local governance policies will be followed.