Clinical trial · Interventional
Xpert Bladder Monitor: a Non-Invasive Follow-Up Tool for Detecting Relapse in High Grade or High Risk Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Cancer Recurrence | — | UNRESOLVED | — |
| Bladder Tumors | Bladder Neoplasm | ALIAS | 0.90 |
| Bladder (Urothelial, Transitional Cell) Cancer | — | UNRESOLVED | — |
| Cystoscopy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Urinary biomarkers | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- Alternate cystoscopies and urinary biomarkers Xpert Bladder Monitor
- description
- Patients with High Grade or High Risk Bladder Cancer
- interventionNames
- Device: Urinary biomarkers
Primary outcomes (1)
- measure
- Primary objective
- timeFrame
- From enrollment to the end of treatment at 2 years
- description
- 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 outcomes (1)
- measure
- Secondary objective
- timeFrame
- From enrollment to the end of treatment at 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available