Bladder CancerNCT07581496
T1G3R-1 Trial: Detectability and Prognostic Value of ctDNA in T1 G3 Bladder Cancer
An observational study of Bladder Cancer, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
T1G3 bladder cancer is a heterogeneous disease with a high risk of disease persistence after the first TUR-B, understaging, disease progression, bladder removal, and mortality. Current risk stratification is insufficient and needs improvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 35 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 18 Jun 2025to 1 Jun 2030
- How long will I take part?
- 3 Years
- 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: Patients with a proven T1G3 Bladder Cancer
Who may be able to join
- patients > 18 years of age, able to give informed consent as documented by signature,
- patients with a cystoscopically proven bladder cancer, suspicious for T1 stage, who will undergo TUR-B
Who cannot join
- Patients with metastases or concomitant upper tract tumor at diagnosis will
- Patients with non T1 G3 cancers
- Patients with upstaging, either at re-TUR-B or after immediate radical cystectomy
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- Vulnerable persons (e.g. < 18y of age, unable to consent to the study)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Universitätsspital Basel
Basel
Heike Püschel, +41 61 55 65477, Heike.Pueschel@usb.ch
Niklas Simon, +41 61 55 65616, Niklas.Simon@usb.ch
- Recruiting
Luzerner Kantonsspital
Lucerne
Fabian Aschwanden, fabian.aschwanden@luks.ch
Tamara Lötscher, tamara.loetscher@luks.ch
About this study
T1G3 bladder cancer is a heterogeneous disease with a high risk of disease persistence after the first TUR-B, understaging, disease progression, bladder removal, and mortality.
Current risk stratification is insufficient and needs improvement. Ct-DNA could identify patients with disease persistence, progression and could monitor and tailor therapy. It might improve patient risk stratification, avoiding under- and overtreatment, reducing morbidity and mortality.
Primary objective is to investigate the detectability of ct-DNA in T1G3 urothelial bladder cancer patients and build a biobank through collection of different sample types (urine, plasma) in T1G3 bladder cancer patients which allows future retrospective testing.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Detectability of ct-DNA in T1G3 urothelial bladder cancer patients
Primary endpoint is the detectability of ct-DNA in T1G3 urothelial bladder cancer patients, whether there are dynamic changes during the different treatment steps (after TUR-BT, after re-TUR-BT, during instillation therapy) and if ct-DNA is predictive / prognostic in T1G3 urothelial bladder cancer patients.
Measured: From start of treatment 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start18 Jun 2025
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrill Rentsch, Prof., Principal investigator, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581496
- Sponsor's protocol ID
- T1G3R-1
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T1G3R-1 Trial: Detectability and Prognostic Value of ctDNA in T1 G3 Bladder Cancer
- ClinicalTrials.gov ID
- NCT07581496
- Acronym / sponsor ID
- T1G3R-1
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 12 May 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.
T1G3 bladder cancer is a heterogeneous disease with a high risk of disease persistence after the first TUR-B, understaging, disease progression, bladder removal, and mortality.
Current risk stratification is insufficient and needs improvement. Ct-DNA could identify patients with disease persistence, progression and could monitor and tailor therapy. It might improve patient risk stratification, avoiding under- and overtreatment, reducing morbidity and mortality.
Primary objective is to investigate the detectability of ct-DNA in T1G3 urothelial bladder cancer patients and build a biobank through collection of different sample types (urine, plasma) in T1G3 bladder cancer patients which allows future retrospective testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a proven T1G3 Bladder Cancer
Key inclusion criteria (2 listed)
- patients > 18 years of age, able to give informed consent as documented by signature,
- patients with a cystoscopically proven bladder cancer, suspicious for T1 stage, who will undergo TUR-B
Key exclusion criteria (5 listed)
- Patients with metastases or concomitant upper tract tumor at diagnosis will
- Patients with non T1 G3 cancers
- Patients with upstaging, either at re-TUR-B or after immediate radical cystectomy
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- Vulnerable persons (e.g. < 18y of age, unable to consent to the study)
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
Detectability of ct-DNA in T1G3 urothelial bladder cancer patients
Time frame: From start of treatment 36 Months
Primary endpoint is the detectability of ct-DNA in T1G3 urothelial bladder cancer patients, whether there are dynamic changes during the different treatment steps (after TUR-BT, after re-TUR-BT, during instillation therapy) and if ct-DNA is predictive / prognostic in T1G3 urothelial bladder cancer patients.
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 18 May 2026.
- 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.
Cyrill Rentsch, Prof. principal investigator
Universitätsspital Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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 2 inclusion and 5 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 Heike Püschel (+41 61 55 65477, Heike.Pueschel@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detectability of ct-DNA in T1G3 urothelial bladder cancer patients (time frame: From start of treatment 36 Months). 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 18 May 2026.