Muscle-invasive Bladder CancerNCT06373055
Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics
An observational study of Muscle-invasive Bladder Cancer, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Muscle-invasive Bladder Cancer
- What is being tested?
- neoadjuvant chemotherapy followed by radical cystectomy
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2024to Nov 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Do not agree with this study.
- Vulnerable participants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea
Seoul
Won Sik Ham, 02-2228-2310, uroham@yuhs.ac
About this study
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
- Being tested
- neoadjuvant chemotherapy followed by radical cystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapy followed by radical cystectomyOther
combination of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or combination of gemcitabine and cisplatin (GC) followed by radical cystectomy
| Study group | Role | What they receive |
|---|---|---|
| Platinum-based Neoadjuvant Chemotherapy Sensitive Patients | Patients with newly confirmed muscle-invasive bladder cancer who have favorable treatment response to platinum-based neoadjuvant chemotherapy Receives: 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 Receives: Other: neoadjuvant chemotherapy followed by radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- Evaluation of the overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
Measured: 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
- Evaluation of the cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
Measured: 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
- Evaluation of the progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
Measured: 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
- Evaluation of the recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy
Measured: within 10 years after the neoadjuvant chemotherapy and radical cystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completionNov 2033 (estimated)
- Study completionNov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Won Sik Ham, Principal investigator, Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373055
- Sponsor's protocol ID
- 4-2023-1232
- Status last verified
- Apr 2024
- First submitted
- 12 Dec 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics
- ClinicalTrials.gov ID
- NCT06373055
- Acronym / sponsor ID
- 4-2023-1232
- Conditions
- Muscle-invasive Bladder Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- Nov 2033 (estimated)
- Study completion
- Nov 2033 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platinum-based Neoadjuvant Chemotherapy Sensitive Patients | – | Other: neoadjuvant chemotherapy followed by radical cystectomyPatients with newly confirmed muscle-invasive bladder cancer who have favorable treatment response to platinum-based neoadjuvant chemotherapy |
| Platinum-based Neoadjuvant Chemotherapy Resistant Patients | – | Other: neoadjuvant chemotherapy followed by radical cystectomyPatients with newly confirmed muscle-invasive bladder cancer who have unfavorable treatment response to platinum-based neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Do not agree with this study.
- Vulnerable participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant chemotherapy followed by radical cystectomycombination of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or combination of gemcitabine and cisplatin (GC) followed by radical cystectomy | Other | Platinum-based Neoadjuvant Chemotherapy Resistant Patients, Platinum-based Neoadjuvant Chemotherapy Sensitive Patients |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Muscle-invasive Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Non-muscle Invasive Bladder Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
RecruitingObservational study
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Non-Muscle Invasive Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Won Sik Ham principal investigator
Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle-invasive Bladder Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Won Sik Ham (02-2228-2310, uroham@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.