Clinical trial NCT05112523: The Performance of Cancer Risk Genes in the Necessity of Secondary TURBT
Official title: The Performance of Uroepithelial Cancer Risk Genes in the Necessity of Secondary Transurethral Resection of Bladder Tumor for High-risk Non-muscle-invasive Bladder Cancer: A Multicenter Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: Bladder Cancer
TURBT
Liquid biopsy
Uroepithelial cancer risk genes
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Hangzhou Jichenjunchuang Medical Laboratory Company
First posted: 2021-11-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receive a confirmed diagnosis of high-risk NMIBC at each study center and undergo the first TURBT

Brief summary: Investigators performed the Genetron Uro V1 test on the urine of patients before secondary TURBT and compared it with the final pathological results. To analyze the performance of the Genetron Uro V1 method in a study to predict the need for secondary TURBT in high-risk NMIBC patients and the correlation with patient's RFS and OS.

Detailed description: The standard of treatment for patients with non-muscle invasive bladder cancer (NMIBC) is transurethral resection of bladder tumors (TURBT), with postoperative intravesical irrigation treatment options determined by the risk of recurrence. After TURBT surgery, tumor remnants are one of the most important causes of postoperative tumor recurrence. Studies have shown that secondary TURBT can detect residual bladder tumor lesions, obtain more accurate pathological staging, increase recurrence-free survival, improve patient prognosis, and enhance treatment outcomes. Current bladder cancer treatment guidelines recommend secondary TURBT for patients with (1) inadequate first TURBT (2) no muscle tissue in the first TURBT specimen, except for TaG1 and carcinoma in situ (3) stage T1 tumors (4) grade G3 tumors, except for carcinoma in situ. However, at present, the lack of screening methods for the population benefiting from secondary TURBT in clinical practice has led to some patients inevitably receiving overtreatment, increasing patient suffering, and financial costs, and raising the burden of government healthcare.

The genetic test for uroepithelial tumor risk (Genetron Uro V1) is a non-invasive liquid biopsy method based on urine samples, which has high diagnostic efficacy in patients with primary uroepithelial cancer. Investigators performed the Genetron Uro V1 test on the urine of patients before secondary TURBT and compared it with the final pathological results.

To analyze the performance of the Genetron Uro V1 method in a study to predict the need for secondary TURBT in high-risk NMIBC patients and the correlation with patient's RFS and OS.

Eligibility criteria: Inclusion Criteria:

1. Patients with a confirmed diagnosis of high-risk NMIBC at each study center:

   including (1) inadequate first TURBT; (2) absence of muscle tissue in the first TURBT specimen, except for TaG1 and carcinoma in situ alone; (3) stage T1 tumors; (4) grade G3 tumors, except for carcinoma in situ alone; (5) TaG1G2 meeting both multiple, recurrent, and \>3 cm in diameter (or low-grade urothelial epithelial carcinoma)
2. gender is not limited.
3. age ≥ 18 years old.
4. the ability to provide a 100 ml standing urine sample within 3-6 weeks after the first TURBT and before the secondary transurethral resection.
5. agree to provide basic personal clinical information and pathological and imaging data for use in scientific research and sign an informed consent form related to scientific research.
6. consent to perform the genetic testing services involved in the trial.
7. agree to provide monitoring results in the follow-up relapse monitoring process.

Exclusion Criteria:

1. patients with other non-uroepithelial malignancies (including prostate cancer and renal cell carcinoma).
2. patients who failed to undergo secondary transurethral resection.
3. patients with incomplete information on sample pathology.
4. patients with contaminated samples.
5. Patients whose urine samples fail quality control and cannot be re-sampled for valid reasons.
6. Patients whose samples cannot complete the test due to reasonable cause.
7. any condition that, in the opinion of the investigator, may harm the subject or cause the subject to be unable to meet or perform the requirements of the study.
8. Patients who are unable to provide written informed consent.

Primary outcomes:
measure: Concordance analysis of Genetron Uro V1 assay results with gold standard results of secondary TURBT histopathology
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years after surgery
measure: Recurrence-free survival
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The first affiliated hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Qiang Lv, MD，PHD
role: PRINCIPAL_INVESTIGATOR
References: