An interventional study of Urinary biomarkers in Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer and Bladder Tumors, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Not applicable, Interventional, and Diagnostic
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.
STUDY DESIGN
This prospective study is designed to assess the use of Xpert Bladder Monitor during the follow-up of patients with high grade bladder cancer. As per the guidelines, the study involves the following schedule:
The same schedule will be followed for the second year of follow-up. In the event of a positive Xpert Bladder Monitor result during follow-up, a cystoscopy will be scheduled. The study aims to enroll 50 patients for an initial follow-up of 2 years, alternating between cystoscopy and Xpert Bladder Monitor: this will involve 200 tests. The study expects to enroll patients in approximately 24 months, and with a 24-month follow-up, the study will be completed within 48 months. During the study, the possibility of extending it to a 5-year follow-up with six-monthly checks will be evaluated.The potential risk is to is not recognize a disease recurrence during follow-up at an early convenient stage. The potential benefits are related to the possibility of avoid an invasive procedure like cystoscopy which is expensive, with potential harms, surgeon-related and with a long waiting list. If patient has a positive Xpert Bladder Monitor, a cystoscopy will be performed within 30 days to verify the result.
ELEGIBILITY CRITERIA Participants will be recruited to the study only if they meet all of the inclusion criteria and none of the exclusion criteria.
4.1 Inclusion Criteria
4.2 Exclusion Criteria
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 169 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with High Grade or High Risk Bladder Cancer
Device: Urinary biomarkers
In 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.
Time frame: From enrollment to the end of treatment at 2 years
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).
Time frame: From enrollment to the end of treatment at 2 years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano