NCT06373055|Recruiting
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Sponsor study identifier
observational
250
1 country
1
Study Start
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 12, 2023
Actual (reported)April 18, 2024
Actual (reported)May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles
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.
At the end of 2 cycles of neoadjuvant chemotherapy (each cycle is 14 days (for ddMVAC) / 28 days (for GC))
overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
within 10 years after the 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
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
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
Patients with newly confirmed muscle-invasive bladder cancer who have favorable treatment response to platinum-based neoadjuvant chemotherapy
Patients with newly confirmed muscle-invasive bladder cancer who have unfavorable treatment response to platinum-based neoadjuvant chemotherapy
combination of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or combination of gemcitabine and cisplatin (GC) followed by radical cystectomy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Drop-out criteria: * Not following treatment schedule (transurethral resection of bladder tumor -\> neoadjuvant chemotherapy -\> radical cystectomy) * Severe side effects during chemotherapy * Do not want to participate in the study.
Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea
Seoul, South Korea
Won Sik Ham
Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea
First Submitted
December 12, 2023
First Posted
April 18, 2024
Study Start
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2033
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 18, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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