Xpert Bladder Monitor: a Non-Invasive Follow-Up Tool for Detecting Relapse in High Grade or High Risk Bladder Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

Main objectives:

Qualitative and quantitative monitoring of recurrences in patients with a previous diagnosis of high-grade bladder cancer at high risk of persistence/recurrence.

Endpoints: Presence or absence of mRNA in urine with a dichotomous result; concordance between Xpert BM and histopathological examination

Clinical relevance: reduces by half the number of (invasive) cystoscopies during follow-up. The non-invasive nature of the test could improve patient compliance with follow-up. Interventional study because it would reduce by half the number of cystoscopies during follow-up of bladder cancer which is considered the gold standard in the follow-up of this tumor. However, these markers are already CE validated and described in the European guidelines and for this reason the risk would be low.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf

NMIBC high grade or high risk (already subjected to or currently undergoing treatment with BCG).

No contraindications to surgery

Disqualifiers

Inability or unwillingness of the participant or their legal representative to provide written informed consent

Absolute contraindications to surgery or cystoscopy

Patients who have previously participated in clinical protocols involving chemotherapy drugs or immunotherapy

Patients with multiple recurrent tumors eligible for cystectomy or Muscle-Invasive Bladder Cancer (MIBC)

Trial design

Treatments tested in this trial

  • Urinary biomarkers

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

This trial has no locations