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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorYonsei University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Do not agree with this study.

Vulnerable participants

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • neoadjuvant chemotherapy followed by radical cystectomy

    Other intervention

    combination of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or combination of gemcitabine and cisplatin (GC) followed by radical cystectomy

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Platinum-based Neoadjuvant Chemotherapy Sensitive Patients1 intervention
Group B: Platinum-based Neoadjuvant Chemotherapy Resistant Patients1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At the end of 2 cycles of neoadjuvant chemotherapy (each cycle is 14 days (for ddMVAC) / 28 days (for GC))

Secondary outcomes

1

overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy

\- Evaluation of the overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy

Time frame
within 10 years after the neoadjuvant chemotherapy and radical cystectomy
2

cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy

\- Evaluation of the cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy

Time frame
within 10 years after the neoadjuvant chemotherapy and radical cystectomy
3

progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy

\- Evaluation of the progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy

Time frame
within 10 years after the neoadjuvant chemotherapy and radical cystectomy
4

recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy

\- Evaluation of the recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy

Time frame
within 10 years after the neoadjuvant chemotherapy and radical cystectomy

Other outcomes

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