Muscle-invasive Bladder Cancer
Conditions
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.
Interventions
OTHERneoadjuvant 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
Sponsors
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Age ≥18.
Exclusion criteria
* Do not agree with this study. * Vulnerable participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
South Korea
Contacts
Primary ContactWon Sik Ham
Outcome results
None listed