NCT06373055

Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients by causing treatment toxicity and surgical delays. Therefore, treatment tailored specifically to the individual patient based on the genetic and/or molecular profile of the patient is urgently needed. Among patients scheduled for neoadjuvant chemotherapy, the investigators should differentiate between patients who will be highly effective with neoadjuvant chemotherapy and those who will not, and preferentially select other treatments including radical cystectomy in the patients with high probability of failure to neoadjuvant chemotherapy. However, there is no standard which patients would benefit from neoadjuvant chemotherapy. This study plans to predict treatment response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer by analyzing genetic and molecular profiles of tumor tissues obtained through transurethral bladder tumor resection.

Conditions

• Muscle-invasive Bladder Cancer

Interventions

Type	Name	Description
OTHER	neoadjuvant chemotherapy followed by radical cystectomy	combination of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or combination of gemcitabine and cisplatin (GC) followed by radical cystectomy

Timeline

• Start date: 2024-05-01
• Primary completion: 2033-11-01
• Completion: 2033-11-01
• First posted: 2024-04-18
• Last updated: 2024-04-18

Locations

1 site across 1 country: South Korea