T1G3R-1 Trial: Detectability and Prognostic Value of ctDNA in T1 G3 Bladder Cancer

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsspital Basel, Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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)

Treatment and study plan

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heike Püschel

CONTACT

[email protected]

+41 61 55 65477

Niklas Simon

CONTACT

[email protected]

+41 61 55 65616

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2030
First posted: May 12, 2026
Registry last updated: May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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