Actively Recruiting
Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Using Spatial Transcriptomics
Led by Yonsei University · Updated on 2024-04-18
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how to better predict which patients with muscle-invasive bladder cancer will respond well to neoadjuvant chemotherapy. This study focuses on analyzing genetic and molecular profiles from tumor tissues obtained through transurethral bladder tumor resection to identify those likely to benefit from chemotherapy. The goal is to tailor treatment more effectively, avoiding unnecessary toxicity and delays for patients unlikely to respond, and guiding them toward alternative treatments such as radical cystectomy. Participants in this observational study receive platinum-based neoadjuvant chemotherapy, either with a combination of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or a combination of gemcitabine and cisplatin (GC), followed by radical cystectomy surgery. Patients are grouped based on whether they have a favorable or unfavorable response to chemotherapy as determined by their genetic and molecular tumor profiles. During the study, researchers collect tumor tissue samples at the time of bladder tumor resection to analyze genetic and molecular markers. The primary goal is to identify responders after two cycles of chemotherapy. Long-term outcomes such as overall survival, cancer-specific survival, progression-free survival, and recurrence-free survival will be monitored for up to 10 years following chemotherapy and surgery. Participants are expected to be actively involved by providing tissue samples and consenting to follow-up assessments over time.
CONDITIONS
Brief Title
Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 �b518 years
You will not qualify if you...
- Do not agree with this study
- Vulnerable participants
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 cycles of chemotherapy (each cycle is 14 days for ddMVAC or 28 days for GC) followed by surgery
Participants receive neoadjuvant chemotherapy followed by radical cystectomy.
Visits occur during chemotherapy cycles and surgery scheduling
Duration - Up to 10 years after neoadjuvant chemotherapy and radical cystectomy
Participants are monitored for overall survival, cancer-specific survival, progression-free survival, and recurrence-free survival after treatment.
Periodic follow-up visits over 10 years
Trial Site Locations
Total: 1 location
1
Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea
Seoul, South Korea
Actively Recruiting
Research Team
W
Won Sik Ham
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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