Clinical trial NCT06373055: Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics
Official title: Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Muscle-invasive Bladder Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Primary outcomes:
measure: Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles
timeFrame: At the end of 2 cycles of neoadjuvant chemotherapy (each cycle is 14 days (for ddMVAC) / 28 days (for GC))
Secondary outcomes:
measure: overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
timeFrame: within 10 years after the neoadjuvant chemotherapy and radical cystectomy
measure: cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
timeFrame: within 10 years after the neoadjuvant chemotherapy and radical cystectomy
measure: progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
timeFrame: within 10 years after the neoadjuvant chemotherapy and radical cystectomy
measure: recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
timeFrame: within 10 years after the neoadjuvant chemotherapy and radical cystectomy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea
Study officials:
affiliation: Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea
name: Won Sik Ham
role: PRINCIPAL_INVESTIGATOR
References: