About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suspicious of bladder cancer scheduled to have transurethral resection of bladder tumor
Consent to the provision of their biospecimen.
Willing to cooperate with this study and comply with the restrictions.
Voluntarily signed the consent form for participation in the study.
Disqualifiers
Do not agree with this study.
Vulnerable participants
Trial population
Drop-out criteria: * Not following treatment schedule (transurethral resection of bladder tumor -\> neoadjuvant chemotherapy -\> radical cystectomy) * Severe side effects during chemotherapy * Do not want to participate in the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
neoadjuvant chemotherapy followed by radical cystectomy
Other interventioncombination of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or combination of gemcitabine and cisplatin (GC) followed by radical cystectomy
Treatment groups
Trial outcomes
Primary outcomes
Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles
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 outcomes
overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
\- Evaluation of the overall 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
\- 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
\- Evaluation of the progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
\- Evaluation of the recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
Sponsors and contacts
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