Bladder (Urothelial, Transitional Cell) CancerLIBERONCT06751667
Xpert Bladder Monitor: a Non-Invasive Follow-Up Tool for Detecting Relapse in High Grade or High Risk Bladder Cancer
A study testing Urinary biomarkers in people with Bladder (Urothelial, Transitional Cell) Cancer and Bladder Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer, Bladder Tumors
- What is being tested?
- Urinary biomarkers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
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:
- At the first outpatient check-up after diagnosis, patients will undergo cystoscopy and urinary cytology at 3 months.
- As follow-up continues, at 6 months, Xpert Bladder Monitor and 3 days urinary cytology will be performed instead of cystoscopy.
- As follow-up continues, at 9 months, standard monitoring with cistoscopy and 3 days cytology on voided urine is provided .
- As follow-up continues, at 12 months, another Xpert Bladder Monitor and 3 days urinary cytology will be performed.
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
- 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
4.2 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)
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer, Bladder Tumors, Bladder Cancer Recurrence, Cystoscopy
- Being tested
- Urinary biomarkers
- Keywords
- Xpert Bladder Monitor, Gene Xpert
- Medical subject headings
- Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary biomarkersDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Alternate cystoscopies and urinary biomarkers Xpert Bladder Monitor | Active comparator | Patients with High Grade or High Risk Bladder Cancer Receives: Device: Urinary biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 2 years
Secondary outcomes (1)
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).
Measured: From enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Nicolai, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751667
- Sponsor's protocol ID
- INT 112/24
- Acronym
- LIBERO
- Status last verified
- Nov 2024
- First submitted
- 20 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xpert Bladder Monitor: a Non-Invasive Follow-Up Tool for Detecting Relapse in High Grade or High Risk Bladder Cancer
- ClinicalTrials.gov ID
- NCT06751667
- Acronym / sponsor ID
- LIBERO / INT 112/24
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer, Bladder Tumors, Bladder Cancer Recurrence, Cystoscopy
- Keywords
- Xpert Bladder Monitor, Gene Xpert
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- At the first outpatient check-up after diagnosis, patients will undergo cystoscopy and urinary cytology at 3 months.
- As follow-up continues, at 6 months, Xpert Bladder Monitor and 3 days urinary cytology will be performed instead of cystoscopy.
- As follow-up continues, at 9 months, standard monitoring with cistoscopy and 3 days cytology on voided urine is provided .
- As follow-up continues, at 12 months, another Xpert Bladder Monitor and 3 days urinary cytology will be performed.
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
- 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
4.2 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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alternate cystoscopies and urinary biomarkers Xpert Bladder Monitor | Active comparator | Device: Urinary biomarkersPatients with High Grade or High Risk Bladder Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary biomarkersIn 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 | Device | Alternate cystoscopies and urinary biomarkers Xpert Bladder Monitor |
Primary outcome
Primary objective
Time frame: From enrollment to the end of treatment at 2 years
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.
1 secondary outcome
Secondary objective
Time frame: From enrollment to the end of treatment at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary biomarkers in people with Bladder (Urothelial, Transitional Cell) Cancer and Bladder Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Macchi, Medical Doctor (+39 3381840185, alberto.macchi@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: From enrollment to the end of treatment at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.