NCT Number: NCT07180212
Non-muscle-invasive bladder cancer (NMIBC) is usually treated with surgery to remove the tumor (transurethral resection of bladder tumor, or TURBT), often followed by bladder-instilled medications to reduce the chance of the cancer coming back. Even with this treatment, high-grade NMIBC can return or progress, so patients need regular check-ups, usually with cystoscopy (a camera examination of the bladder) and urine cytology.
Cystoscopy is effective but invasive, can cause discomfort, and carries risks such as infection and bleeding. This makes follow-up costly and sometimes burdensome for patients.
This study is testing whether a urine tumor DNA (utDNA) test - a type of "liquid biopsy" that detects cancer-related DNA changes in urine - can help guide the timing of cystoscopy for people with high-risk or very high-risk NMIBC. utDNA testing is non-invasive and has shown high accuracy in detecting bladder cancer, sometimes spotting signs of recurrence earlier than standard methods.
By combining utDNA testing with cystoscopy, we hope to safely reduce the number of unnecessary cystoscopies without missing cancer recurrences. The study will evaluate whether this approach can make bladder cancer follow-up more comfortable, more precise, and more efficient.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Xingtai People's Hospital, Xingtai, Hebei, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A.Second transurethral resection of bladder tumor (re-TURBT), or B.Complete initial TURBT with negative basal margins, peripheral margins, and multiple site biopsies, with pathological specimens including detrusor muscle and showing no residual tumor, and negative urine cytology at 2 weeks post-surgery.
Exclusion criteria
1.History of upper urinary tract malignancy (ureter or renal pelvis) within the past 5 years or concurrent diagnosis of upper urinary tract urothelial carcinoma.
Participants undergo urine tumor DNA (utDNA) testing and urine cytology every 3 months, and cystoscopy once per year. If either utDNA or urine cytology is positive, an additional cystoscopy will be performed. If urine cytology is positive but cystoscopy is negative, or if two consecutive utDNA tests are positive while cystoscopy remains negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.
Participants undergo cystoscopy and urine cytology every 3 months as per standard high-risk NMIBC surveillance. If urine cytology is positive but cystoscopy is negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.
Time frame: Up to 24 months from randomization.
Time from randomization to the first histologically confirmed intravesical tumor recurrence (any grade/stage).
Time frame: Up to 24 months from randomization.
The mean number of cystoscopic examinations per patient within 2 years was calculated for both the intervention group and the control group. This measure represents the average total number of cystoscopy procedures undergone by each participant during the 24-month follow-up period.
Time frame: Up to 24 months from randomization.
Time from randomization to pathologic progression to muscle-invasive bladder cancer (≥T2), any newly diagnosed upper tract urothelial carcinoma (UTUC), distant metastasis from urothelial carcinoma, radical cystectomy or nephroureterectomy performed for oncologic progression, or urothelial carcinoma-specific death, whichever occurs first.
Time frame: From randomization to 24 months.
Sensitivity is defined as the proportion of surveillance visits with histologically confirmed recurrence in which utDNA testing performed at the same visit is positive.
Time frame: From randomization to 24 months.
Specificity is defined as the proportion of surveillance visits without recurrence in which utDNA testing is negative.
Time frame: From randomization to 24 months.
Proportion of utDNA-positive surveillance visits with confirmed recurrence.
Time frame: From randomization to 24 months.
Proportion of utDNA-negative surveillance visits without recurrence.
Time frame: Up to 24 months from randomization.
Health-related quality of life (HRQoL) directly reported by patients without clinician interpretation, measured using the EQ-5D-5L questionnaire.
Time frame: Up to 24 months from randomization
Health-related quality of life directly reported by patients without clinician interpretation, assessed using the EORTC QLQ-C30 questionnaire.
Contact information is provided by the study sponsor or research team.
Tianjin Medical University Second Hospital
Other
The Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multicenter Clinical Study (Truce-LB02)
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.
Published trials that share one or more normalized conditions with this study.
NCT07475403
Bladder Cancer, Female Urogenital Diseases
Tianjin, China
View Trial DetailsNCT07187635
Bladder Cancer, Female Urogenital Diseases
Nanchang, Anhui, China
View Trial DetailsNCT07130578
Bladder Cancer, Carcinoma
Tianjin, China
View Trial DetailsNCT05415631
Artificial Intelligence, Bladder Cancer
Amiens, France
View Trial Details