Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics
- Conditions
- Muscle-invasive Bladder Cancer
- Interventions
- Other: neoadjuvant chemotherapy followed by radical cystectomy
- Registration Number
- NCT06373055
- Lead Sponsor
- Yonsei University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Platinum-based Neoadjuvant Chemotherapy Resistant Patients neoadjuvant chemotherapy followed by radical cystectomy Patients with newly confirmed muscle-invasive bladder cancer who have unfavorable treatment response to platinum-based neoadjuvant chemotherapy Platinum-based Neoadjuvant Chemotherapy Sensitive Patients neoadjuvant chemotherapy followed by radical cystectomy Patients with newly confirmed muscle-invasive bladder cancer who have favorable treatment response to platinum-based neoadjuvant chemotherapy
- Primary Outcome Measures
Name Time Method Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles At the end of 2 cycles of neoadjuvant chemotherapy (each cycle is 14 days (for ddMVAC) / 28 days (for GC)) Evaluation of the treatment response to neoadjuvant chemotherapy of muscle-invasive bladder cancer patients by imaging (CT and/or MRI) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and correlate with the genetic and molecular profiles of samples (tissue, urine, and blood) analyzed by spatial transcriptomics.
- Secondary Outcome Measures
Name Time Method recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy within 10 years after the neoadjuvant chemotherapy and radical cystectomy - Evaluation of the recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy within 10 years after the neoadjuvant chemotherapy and radical cystectomy - Evaluation of the cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy within 10 years after the neoadjuvant chemotherapy and radical cystectomy - Evaluation of the progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy within 10 years after the neoadjuvant chemotherapy and radical cystectomy - Evaluation of the overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
Trial Locations
- Locations (1)
Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea
🇰🇷Seoul, Korea, Republic of