The impact of transurethral en bloc resection on the dissemination of circulating tumor cells and tumor DNA in NMIBC compared with conventional TUR-B

The impact of transurethral en bloc resection on the dissemination of circulating tumor cells and tumor DNA in NMIBC compared with conventional TUR-B - TRI-B-LIQUID study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039492

Enrollment

Registered

2026-03-13

Start date

2025-06-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C67

Interventions

Group 1: Surgical resection of bladder tumor: Transurethral resection of bladder tumor using an electrocautery loop (TUR-B) Group 2: Surgical resection of bladder tumor: Transurethral en bloc resectio

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Provision of written informed consent after patient education Age = 18 years Cystoscopically confirmed bladder tumor (initial diagnosis or recurrence) Tumor size = 6 cm

Exclusion criteria

Exclusion criteria: Any circumstances that make study participation undesirable for the subjects No written informed consent provided Bladder tumor = 5 mm = 5 malignant-suspected intravesical lesions Intravesical instillation therapy within the last 8 weeks Muscle-invasive bladder tumor Presence of metastasis Bladder tumor too large to be resected en bloc Patients unable to provide consent Benign histological finding

Design outcomes

Primary

Measure	Time frame
Comparison between treatment groups with regard to the number of circulating tumor cells (CTCs) in peripheral blood. For the defined endpoints, CTCs and circulating tumor DNA (ctDNA, see below) will be analyzed in blood and urine samples preoperatively, intraoperatively, and 12 h postoperatively using the methodology described below.	—

Secondary

Measure	Time frame
1. Comparison between treatment groups with regard to the shedding of circulating tumor DNA (ctDNA) into peripheral blood. 2. Comparison between treatment groups regarding the number of circulating tumor cells (CTCs) in urine/irrigation fluid. 3. Establishment of a database for the systematic characterization of circulating tumor cells (CTCs) in urine. 4. Comparison between treatment groups with respect to the shedding of circulating tumor DNA (ctDNA) into urine/irrigation fluid. 5. Molecular characterization of CTCs with respect to the following markers: FGFR3, PIK3CA, ERBB2, TP53, androgen receptor (AR) and estrogen receptor 1 alpha/beta (ERa/ß), PD-1 and PD-L1, HER2/neu, NECTIN2, and Trop-2. 6. Sequencing of the resected tumor tissue to identify tumor-specific genomic alterations. 7. Demonstration that transurethral en bloc resection results in lower recurrence and progression rates at 3 and 12 months in patients with non–muscle-invasive bladder cancer (NMIBC) compared with conventional transurethral resection of bladder tumor. Follow-up will be performed in accordance with guideline recommendations at 3 and 12 months using cystoscopy and urine cytology. 8. Establishment of a primary cell culture derived from isolated circulating tumor cells. 9. Development of organoid models based on these cell cultures for personalized drug testing. 10. Proportion of detrusor muscle and negative resection margins in the histopathological specimen. 11. Number of tumors resected en bloc in the TUeb+HJ and TUeb-HJ groups.	—

Measure

Time frame

1. Comparison between treatment groups with regard to the shedding of circulating tumor DNA (ctDNA) into peripheral blood. 2. Comparison between treatment groups regarding the number of circulating tumor cells (CTCs) in urine/irrigation fluid. 3. Establishment of a database for the systematic characterization of circulating tumor cells (CTCs) in urine. 4. Comparison between treatment groups with respect to the shedding of circulating tumor DNA (ctDNA) into urine/irrigation fluid. 5. Molecular characterization of CTCs with respect to the following markers: FGFR3, PIK3CA, ERBB2, TP53, androgen receptor (AR) and estrogen receptor 1 alpha/beta (ERa/ß), PD-1 and PD-L1, HER2/neu, NECTIN2, and Trop-2. 6. Sequencing of the resected tumor tissue to identify tumor-specific genomic alterations. 7. Demonstration that transurethral en bloc resection results in lower recurrence and progression rates at 3 and 12 months in patients with non–muscle-invasive bladder cancer (NMIBC) compared with conventional transurethral resection of bladder tumor. Follow-up will be performed in accordance with guideline recommendations at 3 and 12 months using cystoscopy and urine cytology. 8. Establishment of a primary cell culture derived from isolated circulating tumor cells. 9. Development of organoid models based on these cell cultures for personalized drug testing. 10. Proportion of detrusor muscle and negative resection margins in the histopathological specimen. 11. Number of tumors resected en bloc in the TUeb+HJ and TUeb-HJ groups.

—

Countries

Germany

Contacts

Public ContactGeorgios Gakis

Universitätsklinikum Halle (Saale) : Universitätsklinik und Poliklinik für Urologie

direktor.urologie@uk-halle.de+493455571446

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026