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.
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
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)
Single group
Urinary biomarkers
DeviceIn a bid to reduce or replace surveillance cystoscopies multiple urinary biomarkers have been evaluated for the follow-up of the bladder cancer patients. These device will reduce the number of cystoscopies
Primary objective
The primary objective of this study is to qualitatively and quantitatively monitor recurrences in patients previously diagnosed with high grade or high risk bladder cancer.
Secondary objective
The secondary objective of the study is to verify the sensitivity, specificity and negative predictive value of miRNAs in patients with high risk bladder cancer as a laboratory tool for follow-up, to reduce an invasive test such as cystoscopy. The study also seeks to identify the ideal candidates for Xpert BM by assessing the test's specificity based on histopathological examination of cistoscopy biopsy (cold biopsy or Transurethral Resection of Bladder (TURB) samples).
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This trial is not recruiting at the moment. You can still explore other options:
