An observational study in Muscle-Invasive Bladder Cancer (MIBC), Upper Tract Urothelial Carcinoma and Urothelial Carcinoma (UC), sponsored by AZ Sint-Lucas Gent. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by AZ Sint-Lucas Gent · Observational
Among 38 studies in Carcinoma, Transitional Cell with a site in Belgium — 5 open to participants now, 12 under way, 2 of them phase 3. Carcinoma, Transitional Cell · Belgium.
Among the 38 studies in Carcinoma, Transitional Cell with a site in Belgium, this one is the only one that started in 2025, is one of 2 observational ones, reaches primary completion later than 9 of the 11 other live ones, and was the 38th registered.
633 studies on the registry are indexed under Carcinoma, Transitional Cell; 181 are open to participants now.
Browse Carcinoma, Transitional Cell studies →5 of the 38 studies in Carcinoma, Transitional Cell with a site in Belgium are open now. Recruiting first, the newest first:
Daiichi Sankyo · Sites in Belgium, United States, Argentina and 15 more countries
Seagen, a wholly owned subsidiary of Pfizer · Sites in Belgium, United States, Argentina and 9 more countries
Exelixis · Sites in Belgium, United States, Australia and 10 more countries
Universitair Ziekenhuis Brussel · Sites in Belgium
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 147 Carcinoma, Transitional Cell studies recruiting now, 121 (82%) set no upper age limit and 11 (7%) stop at 75 or younger; 4 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 21 · Phase 3 8
First in 2004; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 70 is below the median of 300 across 107 observational studies indexed under Carcinoma, Transitional Cell.
Median enrollment 179 across the 36 interventional studies, 1,413 across the 2 observational. Of the 26 that completed or were terminated, 16 (62%) have results posted.
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32 of 38 have an industry lead sponsor. The 10 most frequent:
AZ Sint-Lucas Gent is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
AZ Sint-Lucas Gent has 1 study filed under Carcinoma, Transitional Cell — fewer than ten, so there is no comparison to draw.
5 of the studies in Carcinoma, Transitional Cell with a site in Belgium that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT05911295Phase 3Seagen, a wholly owned subsidiary of PfizerDisitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 | 2027-01-29 |
| NCT04879329Seagen, a wholly owned subsidiary of PfizerA Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 | 2026-12-11 |
| NCT05176483ExelixisStudy of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors | 2027-01-31 |
| NCT07756437AZ Sint-Lucas GentValidation of a Circulating Tumor DNA Blood Test in Muscle-Invasive Bladder and Upper Tract Urothelial Cancer | 2027-09-30 |
Among the 38 studies in Carcinoma, Transitional Cell with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This prospective observational study evaluates a blood-based circulating tumor DNA (ctDNA) test in patients with muscle-invasive bladder cancer or upper tract urothelial cancer. ctDNA consists of small fragments of tumor DNA that can sometimes be detected in the blood.
In this study, DNA from tumor tissue obtained during routine diagnostic or surgical procedures will be analyzed to identify tumor-specific mutations. Blood samples collected during routine clinical care will then be tested to determine whether the same mutations can be detected in plasma ctDNA.
The main purpose is to assess how well the internally developed ctDNA assay detects tumor-specific mutations compared with tumor tissue sequencing. The study will also explore whether ctDNA results after treatment are associated with recurrence or remission during two years of follow-up, and whether changes in ctDNA levels during treatment are associated with pathological response.
This study does not assign participants to a treatment and does not require additional blood draws beyond routine care. Treating physicians will remain blinded to ctDNA results during the study, so the test results will not influence clinical decisions.
Muscle-invasive bladder cancer and muscle-invasive upper tract urothelial carcinoma are associated with a relevant risk of recurrence or progression after treatment. Current follow-up mainly relies on imaging, pathology, and clinical assessment. Circulating tumor DNA (ctDNA) may provide additional information on tumor burden, minimal residual disease, and treatment response, but clinical implementation remains limited by cost, logistics, and the need for local assay validation.
This study evaluates an internally developed, tumor-informed ctDNA workflow in patients treated at AZ Sint-Lucas Gent. Tumor DNA will be extracted from available formalin-fixed paraffin-embedded tumor tissue, such as tissue obtained during transurethral resection of bladder tumor, upper tract biopsy, nephro-ureterectomy, cystectomy, or biopsy of metastatic disease. Targeted next-generation sequencing will be used to identify patient-specific somatic mutations in the tumor tissue.
When tumor-specific mutations are identified, matched plasma samples collected during routine clinical care will be analyzed for the same mutations. Cell-free DNA will be extracted from plasma and ctDNA detection will be performed using a tumor-informed approach, primarily by digital droplet PCR for known tumor-specific mutations. Mutations that cannot be assessed by digital droplet PCR may be further evaluated using next-generation sequencing.
Blood samples will be obtained only as part of routine diagnostic, staging, treatment, or follow-up blood draws. The study does not assign participants to a specific treatment and does not require additional study-specific therapeutic interventions. Patients will receive standard clinical care according to institutional practice.
Treating physicians will remain blinded to the ctDNA results during the study. The ctDNA results are investigational and will not guide treatment decisions during the study period. Clinical, pathological, treatment, molecular, and follow-up data will be collected to assess the performance of the assay and to explore associations between ctDNA status, treatment response, recurrence, progression, and remission over two years of follow-up.
The study is intended to support internal validation of a local ctDNA assay and to determine whether this approach may be feasible for future integration into clinical workflows for urothelial cancer monitoring.
Adult patients with muscle-invasive bladder cancer or suspected muscle-invasive upper tract urothelial carcinoma treated at AZ Sint-Lucas Gent. Participants must have available tumor tissue for DNA extraction and matched plasma samples obtained during routine clinical care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Concurrent active diagnosed within the past 5 years.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Performance of Plasma ctDNA for Detecting Tumor-Specific Mutations
Concordance between tumor-specific somatic mutations identified in tumor tissue and the same mutations detected in matched plasma-derived ctDNA. Diagnostic performance of the internally developed ctDNA assay will be assessed using sensitivity, specificity, positive predictive value, and negative predictive value, with tumor tissue sequencing as the reference standard.
Time frame: From enrollment until completion of tumor tissue sequencing and matched plasma ctDNA analysis, up to 6 months
Association Between Post-Treatment ctDNA Positivity and Disease Recurrence or Progression
Association between ctDNA positivity after surgery or radiotherapy, with or without neoadjuvant or adjuvant systemic treatment, and disease recurrence or progression during the first two years of follow-up.
Time frame: Up to 2 years after surgery or radiotherapy
Association Between Post-Treatment ctDNA Negativity and Disease Remission
Association between ctDNA negativity after surgery or radiotherapy, with or without neoadjuvant or adjuvant systemic treatment, and absence of disease recurrence or progression during the first two years of follow-up.
Time frame: Up to 2 years after surgery or radiotherapy
Association Between Preoperative ctDNA Negativity and Pathological T0 Status
Association between ctDNA negativity before surgery, with or without neoadjuvant systemic treatment, and pathological T0 status on the cystectomy specimen.
Time frame: At cystectomy
Association Between Quantitative ctDNA Decrease During Neoadjuvant Therapy and Pathological Downstaging
Association between a quantitative decrease in ctDNA levels during neoadjuvant therapy and favorable pathological response, defined as tumor downstaging at cystectomy.
Time frame: From start of neoadjuvant therapy until cystectomy, up to 6 months
Time Difference Between ctDNA Rise and Imaging-Detected Disease Relapse
Assessment of whether disease relapse after curative treatment is detected earlier by a rise in ctDNA than by standard imaging studies. The time difference will be measured in months. The protocol lists one primary endpoint and five secondary endpoints, including diagnostic performance, recurrence/remission within two years, pT0 status, pathological downstaging, and earlier relapse detection by ctDNA.
Time frame: Up to 2 years after curative treatment
Plan to share: No — No individual participant data are planned to be shared. The study includes sensitive clinical and molecular data, including tumor sequencing and plasma ctDNA results. Aggregate study results may be published, and additional data sharing may be considered only in anonymized form and subject to applicable ethics, legal, and institutional approvals.
Started Nov 2025 (actual). Primary completion is estimated for Sep 2027, 22 months after the start.
Of 60 observational studies under Carcinoma, Transitional Cell, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
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AZ Sint-Lucas Gent