The Performance of Cancer Risk Genes in the Necessity of Secondary TURBT (RE-TURBT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance analysis of Genetron Uro V1 assay results with gold standard results of secondary TURBT histopathology	Through Concordance analysis of Genetron Uro V1 assay results with gold standard results of secondary TURBT histopathology, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of Genetron Uro V1 detected before secondary TURBT are measured.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	To analyze the performance of the Genetron Uro V1 method in a study to predict the correlation with patient OS.	2 years after surgery
Recurrence-free survival	To analyze the performance of the Genetron Uro V1 method in a study to predict the correlation with patient RFS.	2 years after surgery

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Hangzhou Jichenjunchuang Medical Laboratory Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2020
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (ACTUAL): November 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Liquid biopsy; Bladder Cancer; TURBT; Uroepithelial cancer risk genes
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 2021-SR-277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No