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

NCT07581496 | Recruiting

• 1 other identifier: T1G3R-1
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of treatment 36 Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a proven T1G3 Bladder Cancer

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (2)

Universitätsspital Basel

Basel, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, Switzerland

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Cyrill Rentsch, Prof.

  Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heike Püschel

CONTACT

+41 61 55 65477; Heike.Pueschel@usb.ch

Niklas Simon

CONTACT

+41 61 55 65616; niklas.simon@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: June 18, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

CH (2)