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NCT Number: NCT06373055

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

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.

Recruiting

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Key information

Conditions

Muscle-invasive Bladder Cancer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Seoul, South Korea

Location status: Recruiting

Location contact

Won Sik Ham

CONTACT

[email protected]

02-2228-2310

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles

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

    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.

Secondary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Won Sik Ham

CONTACT

[email protected]

02-2228-2310

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Apr 18, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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