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

NCT05112523 | Unknown

• 1 other identifier: 2021-SR-277
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Bladder Cancer; TURBT; Liquid biopsy; Uroepithelial cancer risk genes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall survival

  2 years after surgery

• Recurrence-free survival

  2 years after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Hangzhou Jichenjunchuang Medical Laboratory Company: collaborator

Study Sites (1)

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The genes of tumor exfoliated cells in urine

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Qiang Lv, MD，PHD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingkai Cai

CONTACT

+86 15206213500; lingkaicai1996@163.com

Qiang Lv, MD，PHD

CONTACT

+86 13505196501; doctorlvqiang@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 9, 2021
• Study Start: December 20, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2023
• Last Updated: November 9, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)