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

Yonsei University

Status: Enrolling

Conditions: Muscle-invasive Bladder Cancer

Treatments: Other: neoadjuvant chemotherapy followed by radical cystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06373055

4-2023-1232

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Platinum-based Neoadjuvant Chemotherapy Sensitive Patients

Description:

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

Treatment:

Other: neoadjuvant chemotherapy followed by radical cystectomy

Platinum-based Neoadjuvant Chemotherapy Resistant Patients

Description:

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

Treatment:

Other: neoadjuvant chemotherapy followed by radical cystectomy