Muscle-Invasive Bladder Cancer (MIBC)BLUT-DNANCT07756437
Validation of a Circulating Tumor DNA Blood Test in Muscle-Invasive Bladder and Upper Tract Urothelial Cancer
An observational study of Muscle-Invasive Bladder Cancer (MIBC) and Upper Tract Urothelial Carcinoma, run by AZ Sint-Lucas Gent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Cancer (MIBC), Upper Tract Urothelial Carcinoma, Urothelial Carcinoma (UC)
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Nov 2025to 1 Jun 2029
- Phase
- Observational
- 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
Study population: 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.
Who may be able to join
- Age 18 years or older.
- Histologically confirmed muscle-invasive bladder cancer or suspected muscle-invasive upper tract urothelial carcinoma, stage T2 or higher.
- Availability of tumor tissue from transurethral resection of bladder tumor, ureteroscopic biopsy, biopsy of a metastatic lesion, or nephroureterectomy for DNA extraction.
- Written informed consent provided.
Who cannot join
- Concurrent active malignancy diagnosed within the past 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
AZ Sint-Lucas Gent
Ghent, East Flanders, 9000
Jeroen Van Besien, MD, 003292246650, Secretariaat.Urologie@AZSTLUCAS.BE
loic.baekelandt@azstlucas.be
About this study
Official title: Internal Validation of Circulating Tumor DNA (ctDNA) Sequencing in Muscle-Invasive Bladder Cancer and Upper Tract Urothelial Carcinoma: A Prospective Observational Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Muscle-Invasive Bladder Cancer (MIBC), Upper Tract Urothelial Carcinoma, Urothelial Carcinoma (UC)
- Keywords
- Circulating Tumor DNA, ctDNA, Liquid biopsy, Tumor-Informed Sequencing, Minimal Residual Disease, MRD, Muscle-Invasive Bladder Cancer, Upper Tract Urothelial Carcinoma, Urothelial carcinoma, Next-Generation Sequencing, NGS, Recurrence Monitoring, Treatment response
- Medical subject headings
- Carcinoma, Transitional Cell, Neoplasm, Residual
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until completion of tumor tissue sequencing and matched plasma ctDNA analysis, up to 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years after curative treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start7 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Muscle-Invasive Bladder Cancer (MIBC)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Lucas Gent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756437
- Sponsor's protocol ID
- 2025-18
- Acronym
- BLUT-DNA
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Carrasco R, Ingelmo-Torres M, Gomez A, Trullas R, Roldan FL, Ajami T, Moreno D, Rodriguez-Carunchio L, Alcaraz A, Izquierdo L, Mengual L. Cell-Free DNA as a Prognostic Biomarker for Monitoring Muscle-Invasive Bladder Cancer. Int J Mol Sci. 2022 Oct 3;23(19):11732. doi: 10.3390/ijms231911732.
PubMed 36233035Lindskrog SV, Birkenkamp-Demtroder K, Nordentoft I, Laliotis G, Lamy P, Christensen E, Renner D, Andreasen TG, Lange N, Sharma S, ElNaggar AC, Liu MC, Sethi H, Aleshin A, Agerbaek M, Jensen JB, Dyrskjot L. Circulating Tumor DNA Analysis in Advanced Urothelial Carcinoma: Insights from Biological Analysis and Extended Clinical Follow-up. Clin Cancer Res. 2023 Dec 1;29(23):4797-4807. doi: 10.1158/1078-0432.CCR-23-1860.
PubMed 37782315Nordentoft I, Lindskrog SV, Birkenkamp-Demtroder K, Gonzalez S, Kuzman M, Levatic J, Glavas D, Ptashkin R, Smadbeck J, Afterman D, Lauterman T, Cohen Y, Donenhirsh Z, Tavassoly I, Alon U, Frydendahl A, Rasmussen MH, Andersen CL, Lamy P, Knudsen M, Polak P, Zviran A, Oklander B, Agerbaek M, Jensen JB, Dyrskjot L. Whole-genome Mutational Analysis for Tumor-informed Detection of Circulating Tumor DNA in Patients with Urothelial Carcinoma. Eur Urol. 2024 Oct;86(4):301-311. doi: 10.1016/j.eururo.2024.05.014. Epub 2024 May 29.
PubMed 38811314Powles T, Assaf ZJ, Degaonkar V, Grivas P, Hussain M, Oudard S, Gschwend JE, Albers P, Castellano D, Nishiyama H, Daneshmand S, Sharma S, Sethi H, Aleshin A, Shi Y, Davarpanah N, Carter C, Bellmunt J, Mariathasan S. Updated Overall Survival by Circulating Tumor DNA Status from the Phase 3 IMvigor010 Trial: Adjuvant Atezolizumab Versus Observation in Muscle-invasive Urothelial Carcinoma. Eur Urol. 2024 Feb;85(2):114-122. doi: 10.1016/j.eururo.2023.06.007. Epub 2023 Jul 26.
PubMed 37500339Crupi E, de Padua TC, Marandino L, Raggi D, Dyrskjot L, Spiess PE, Sonpavde GP, Kamat AM, Necchi A. Circulating tumor DNA as a Predictive and Prognostic Biomarker in the Perioperative Treatment of Muscle-invasive Bladder Cancer: A Systematic Review. Eur Urol Oncol. 2024 Feb;7(1):44-52. doi: 10.1016/j.euo.2023.05.012. Epub 2023 Jun 15.
PubMed 37330413
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Validation of Circulating Tumor DNA (ctDNA) Sequencing in Muscle-Invasive Bladder Cancer and Upper Tract Urothelial Carcinoma: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07756437
- Acronym / sponsor ID
- BLUT-DNA / 2025-18
- Conditions
- Muscle-Invasive Bladder Cancer (MIBC), Upper Tract Urothelial Carcinoma, Urothelial Carcinoma (UC)
- Keywords
- Circulating Tumor DNA, ctDNA, Liquid biopsy, Tumor-Informed Sequencing, Minimal Residual Disease, MRD, Muscle-Invasive Bladder Cancer, Upper Tract Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- AZ Sint-Lucas GentUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 10 Aug 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Histologically confirmed muscle-invasive bladder cancer or suspected muscle-invasive upper tract urothelial carcinoma, stage T2 or higher.
- Availability of tumor tissue from transurethral resection of bladder tumor, ureteroscopic biopsy, biopsy of a metastatic lesion, or nephroureterectomy for DNA extraction.
- Written informed consent provided.
Key exclusion criteria (1 listed)
- Concurrent active malignancy diagnosed within the past 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Performance of Plasma ctDNA for Detecting Tumor-Specific Mutations
Time frame: From enrollment until completion of tumor tissue sequencing and matched plasma ctDNA analysis, up to 6 months
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.
5 secondary outcomes
Association Between Post-Treatment ctDNA Positivity and Disease Recurrence or Progression
Time frame: Up to 2 years after surgery or radiotherapy
Association Between Post-Treatment ctDNA Negativity and Disease Remission
Time frame: Up to 2 years after surgery or radiotherapy
Association Between Preoperative ctDNA Negativity and Pathological T0 Status
Time frame: At cystectomy
Association Between Quantitative ctDNA Decrease During Neoadjuvant Therapy and Pathological Downstaging
Time frame: From start of neoadjuvant therapy until cystectomy, up to 6 months
Time Difference Between ctDNA Rise and Imaging-Detected Disease Relapse
Time frame: Up to 2 years after curative treatment
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 10 Aug 2026.
- Background: PubMed 36233035Carrasco R, Ingelmo-Torres M, Gomez A, Trullas R, Roldan FL, Ajami T, Moreno D, Rodriguez-Carunchio L, Alcaraz A, Izquierdo L, Mengual L. Cell-Free DNA as a Prognostic Biomarker for Monitoring Muscle-Invasive Bladder Cancer. Int J Mol Sci. 2022 Oct 3;23(19):11732. doi: 10.3390/ijms231911732.
- Background: PubMed 37782315Lindskrog SV, Birkenkamp-Demtroder K, Nordentoft I, Laliotis G, Lamy P, Christensen E, Renner D, Andreasen TG, Lange N, Sharma S, ElNaggar AC, Liu MC, Sethi H, Aleshin A, Agerbaek M, Jensen JB, Dyrskjot L. Circulating Tumor DNA Analysis in Advanced Urothelial Carcinoma: Insights from Biological Analysis and Extended Clinical Follow-up. Clin Cancer Res. 2023 Dec 1;29(23):4797-4807. doi: 10.1158/1078-0432.CCR-23-1860.
- Background: PubMed 38811314Nordentoft I, Lindskrog SV, Birkenkamp-Demtroder K, Gonzalez S, Kuzman M, Levatic J, Glavas D, Ptashkin R, Smadbeck J, Afterman D, Lauterman T, Cohen Y, Donenhirsh Z, Tavassoly I, Alon U, Frydendahl A, Rasmussen MH, Andersen CL, Lamy P, Knudsen M, Polak P, Zviran A, Oklander B, Agerbaek M, Jensen JB, Dyrskjot L. Whole-genome Mutational Analysis for Tumor-informed Detection of Circulating Tumor DNA in Patients with Urothelial Carcinoma. Eur Urol. 2024 Oct;86(4):301-311. doi: 10.1016/j.eururo.2024.05.014. Epub 2024 May 29.
- Background: PubMed 37500339Powles T, Assaf ZJ, Degaonkar V, Grivas P, Hussain M, Oudard S, Gschwend JE, Albers P, Castellano D, Nishiyama H, Daneshmand S, Sharma S, Sethi H, Aleshin A, Shi Y, Davarpanah N, Carter C, Bellmunt J, Mariathasan S. Updated Overall Survival by Circulating Tumor DNA Status from the Phase 3 IMvigor010 Trial: Adjuvant Atezolizumab Versus Observation in Muscle-invasive Urothelial Carcinoma. Eur Urol. 2024 Feb;85(2):114-122. doi: 10.1016/j.eururo.2023.06.007. Epub 2023 Jul 26.
- Background: PubMed 37330413Crupi E, de Padua TC, Marandino L, Raggi D, Dyrskjot L, Spiess PE, Sonpavde GP, Kamat AM, Necchi A. Circulating tumor DNA as a Predictive and Prognostic Biomarker in the Perioperative Treatment of Muscle-invasive Bladder Cancer: A Systematic Review. Eur Urol Oncol. 2024 Feb;7(1):44-52. doi: 10.1016/j.euo.2023.05.012. Epub 2023 Jun 15.
- Individual participant dataSharing planned: 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle-Invasive Bladder Cancer (MIBC) and Upper Tract Urothelial Carcinoma, run by AZ Sint-Lucas Gent at 1 site in Belgium.
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 1 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jeroen Van Besien, MD (003292246650, Secretariaat.Urologie@AZSTLUCAS.BE), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of Plasma ctDNA for Detecting Tumor-Specific Mutations (time frame: From enrollment until completion of tumor tissue sequencing and matched plasma ctDNA analysis, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07756437, which also lists 5 linked publications.
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 10 Aug 2026.