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

NCT06373055 | Recruiting

• 1 other identifier: 4-2023-1232
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle-invasive Bladder Cancer

Outcome Measures

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.

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

Secondary Outcomes (4)

• 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

Study Arms (2)

Platinum-based Neoadjuvant Chemotherapy Sensitive Patients

Patients with newly confirmed muscle-invasive bladder cancer who have favorable treatment response to platinum-based neoadjuvant chemotherapy

Other: neoadjuvant chemotherapy followed by radical cystectomy

Platinum-based Neoadjuvant Chemotherapy Resistant Patients

Patients with newly confirmed muscle-invasive bladder cancer who have unfavorable treatment response to platinum-based neoadjuvant chemotherapy

Other: neoadjuvant chemotherapy followed by radical cystectomy

Interventions

neoadjuvant chemotherapy followed by radical cystectomy OTHER

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

Platinum-based Neoadjuvant Chemotherapy Resistant Patients; Platinum-based Neoadjuvant Chemotherapy Sensitive Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Do not agree with this study.
• Vulnerable participants

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea

Seoul, South Korea

RECRUITING

Study Officials

• Won Sik Ham

  Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Won Sik Ham

CONTACT

02-2228-2310; uroham@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: April 18, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): November 1, 2033
• Study Completion (Estimated): November 1, 2033
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)