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To Detect the Sensitivity of the UroMark Assay

NCT02781428 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1643

Last updated 2023-12-04

No results posted yet for this study

Summary

This is a prospective multicentre observational study to assess the sensitivity of the UroMark assay to detect bladder cancer in participants with new or recurrent disease. The study will recruit patients with newly detected or recurrent bladder cancer. The reference standard will be histopathological confirmation of tumour stage and (Ta, T1, ≥T2) and grade 1, 2 or 3 diseases with or without CIS, or CIS alone.

Patients with a visual diagnosis of bladder cancer following cystoscopy will be approached and asked to consent for this study. Consenting participants will be provided with a urine sample collection kit and asked to provide a urine sample. Samples can be provided at home and posted to the receiving lab using the stamped addressed envelope. The urine sample must be obtained before TURBT and following TURBT, patients with NMIBC who require surveillance cystoscopy will be asked to provide a urine sample at 3 monthly intervals for up to 2 years.

The study will be conducted in at least 11 NHS trusts. As DETECT II is an observation study requiring provision of a urine sample, it will be possible for patients in DETECT II to be recruited to other trials.

Conditions

Sponsors & Collaborators

  • University College, London

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-26
Primary Completion
2018-12-19
Completion
2018-12-19

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02781428 on ClinicalTrials.gov