The Performance of Cancer Risk Genes in the Necessity of Secondary TURBT

  • STATUS
    Recruiting
  • End date
    Aug 1, 2023
  • participants needed
    200
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
Updated on 14 November 2021
carcinoma
carcinoma in situ
transurethral resection

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.

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.

Details
Condition Bladder Disorders, bladder cancer, Urothelial Cancer, carcinoma of the bladder, bladder tumor, Bladder Cancer, Urologic Cancer, urinary tract neoplasm, Bladder Carcinoma, bladder disorder
Clinical Study IdentifierNCT05112523
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on14 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
\. gender is not limited
\. age 18 years old
\. the ability to provide a 100 ml standing urine sample within 3-6 weeks
after the first TURBT and before the secondary transurethral resection
\. 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
\. consent to perform the genetic testing services involved in the trial
\. agree to provide monitoring results in the follow-up relapse monitoring
process

Exclusion Criteria

patients with other non-uroepithelial malignancies (including prostate cancer and renal cell carcinoma)
patients who failed to undergo secondary transurethral resection
patients with incomplete information on sample pathology
patients with contaminated samples
Patients whose urine samples fail quality control and cannot be re-sampled for valid reasons
Patients whose samples cannot complete the test due to reasonable cause
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
Patients who are unable to provide written informed consent
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