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