NCT06373055 Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics
| NCT ID | NCT06373055 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Muscle-invasive Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2033-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2024-05-01 with a primary completion date of 2033-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Won Sik Ham
PRINCIPAL INVESTIGATOR
Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea
Frequently Asked Questions
Who can join the NCT06373055 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Muscle-invasive Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06373055 currently recruiting?
Yes, NCT06373055 is actively recruiting participants. Contact the research team at uroham@yuhs.ac for enrollment information.
Where is the NCT06373055 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06373055 clinical trial?
NCT06373055 is sponsored by Yonsei University. The principal investigator is Won Sik Ham at Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea. The trial plans to enroll 250 participants.
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