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

Muscle-invasive Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06373055
• Other study ID #: 4-2023-1232
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: November 2033

Study information

• Verified date: April 2024
• Source: Yonsei University
• Contact: Won Sik Ham
• Phone: 02-2228-2310
• Email: uroham[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 2033
• Est. primary completion date: November 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle-invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))
Secondary	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	within 10 years after the neoadjuvant chemotherapy and radical cystectomy
Secondary	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	within 10 years after the neoadjuvant chemotherapy and radical cystectomy
Secondary	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	within 10 years after the neoadjuvant chemotherapy and radical cystectomy
Secondary	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	within 10 years after the neoadjuvant chemotherapy and radical cystectomy