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

NCT06751667 | Not Yet Recruiting DMC

• 1 other identifier: INT 112/24
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Bladder (Urothelial, Transitional Cell) Cancer; Bladder Cancer; Bladder Tumors; Bladder Cancer Recurrence; Cystoscopy

Keywords

Xpert Bladder Monitor; Gene Xpert

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 2 years

Secondary Outcomes (1)

• Secondary objective

  From enrollment to the end of treatment at 2 years

Study Arms (1)

Alternate cystoscopies and urinary biomarkers Xpert Bladder Monitor

ACTIVE COMPARATOR

Patients with High Grade or High Risk Bladder Cancer

Device: Urinary biomarkers

Interventions

Urinary biomarkers DEVICE

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

Alternate cystoscopies and urinary biomarkers Xpert Bladder Monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

MeSH Terms

Conditions

Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Alberto Macchi, Medical Doctor

CONTACT

+39 3381840185; alberto.macchi@istitutotumori.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2032
• Last Updated: December 30, 2024

Record last verified: 2024-11