NCT06751667Not yet recruiting
Xpert Bladder Monitor: a Non-Invasive Follow-Up Tool for Detecting Relapse in High Grade or High Risk Bladder Cancer
Source: ClinicalTrials.gov · Last updated 30 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Diseases
- Bladder cancer
- NCT number
- NCT06751667
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Jan 2025 to the primary completion date, 1 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Absolute contraindications to surgery or cystoscopy
- Patients who have previously participated in clinical protocols involving chemotherapy drugs or immunotherapy
Other illness
- Patients with multiple recurrent tumors eligible for cystectomy or Muscle-Invasive Bladder Cancer (MIBC)
Other
- Inability or unwillingness of the participant or their legal representative to provide written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.