NCT05767528

Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, investigators plan to conduct the 3D in vitro culture PTC drug sensitivity testing of fresh tumor specimen which obtained by endoscopic biopsy or other methods. Through assessing the consistency between the testing results and the patients' neoadjuvant treatment outcomes, they would evaluate the accuracy of PTC drug sensitivity testing and its application value in the individualized precision medicine for muscle-invasive bladder carcinoma.

Detailed description

This is a prospective observational study. In this study, researchers propose to enroll 40 participants above 18 years of age with muscle-invasive bladder carcinoma, who are going to receive the neoadjuvant therapy before surgery. Collecting fresh tumor samples for PTC drug sensitivity testing, conducting neoadjuvant therapy for the subjects simultaneously. By combining PTC prediction results with the patients' clinical treatment process and medication feedback, researchers could estimate the accuracy of PTC drug sensitivity testing. Completion of this research would provide real-world figures to support for the clinical application for PTC drug sensitivity testing, and a method is going to be established to guide the clinical treatment regimen for patients with muscle-invasive bladder carcinoma.

Conditions

• Muscle-Invasive Bladder Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing	Conducting the neoadjuvant therapy of FDA-approved drugs for patients with muscle-invasive bladder carcinoma, culturing the patient-derived tumor-like cell clusters for drug sensitivity testing simultaneously, then assess the accuracy of the diagnostic test by combination and analysis of these results

Timeline

• Start date: 2022-12-08
• Primary completion: 2023-12-08
• Completion: 2024-12-08
• First posted: 2023-03-14
• Last updated: 2023-03-14

Locations

1 site across 1 country: China