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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2033-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Muscle-invasive Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Platinum-based Neoadjuvant Chemotherapy Sensitive Patients

Patients with newly confirmed muscle-invasive bladder cancer who have favorable treatment response to platinum-based neoadjuvant chemotherapy

neoadjuvant chemotherapy followed by radical cystectomy

Intervention Type OTHER

combination of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or combination of gemcitabine and cisplatin (GC) followed by radical cystectomy

Platinum-based Neoadjuvant Chemotherapy Resistant Patients

Patients with newly confirmed muscle-invasive bladder cancer who have unfavorable treatment response to platinum-based neoadjuvant chemotherapy

neoadjuvant chemotherapy followed by radical cystectomy

Intervention Type OTHER

combination of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or combination of gemcitabine and cisplatin (GC) followed by radical cystectomy

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.