UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054119 |
|---|---|
| Receipt number | R000060702 |
| Scientific Title | Predicting neoadjuvant chemotherapy response of muscle-invasive bladder cancer using patient-derived zebrafish xenograft model: multi-institutional prospective study |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/04/11 13:36:16 |
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Basic information
Public title
Predicting neoadjuvant chemotherapy response of muscle-invasive bladder cancer using patient-derived zebrafish xenograft model: multi-institutional prospective study
Acronym
Bladder cancer patient-derived zebrafish xenograft model
Scientific Title
Predicting neoadjuvant chemotherapy response of muscle-invasive bladder cancer using patient-derived zebrafish xenograft model: multi-institutional prospective study
Scientific Title:Acronym
Bladder cancer patient-derived zebrafish xenograft model
Region
| Japan |
Condition
Condition
Muscle-invasive bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Aim of this study is to evaluate response to platinum-based neoadjuvant chemotherapy (NAC) of muscle-invasive bladder cancer (MIBC) by trans-urethral resected bladder specimens transplanted zebrafish xenograft model and compared with pathological and histological diagnosis of radical cystectomy specimens after NAC. And near future we will apply zPDX system to clinical field for precision medicine before treating MIBC with platinum-based neoadjuvant chemotherapy.
Basic objectives2
Others
Basic objectives -Others
Gene expression/mutation analysis of bladder cancer tissue collected transurethrally and residual bladder cancer tissue in radical cystectomy specimens and comparative study of anticancer drug reactivity were conducted to find targets for platinum-based chemotherapy resistant cancer cells.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bladder cancer tissue collected transurethrally before NAC from a patient scheduled to undergo radical cystectomy after neoadjuvant chemotherapy (NAC) with a platinum-based anticancer drug for muscle-invasive bladder cancer. Transplant into zebrafish and evaluate the effectiveness of platinum-based anticancer drugs. The results will be compared with the pathological evaluation of the total cystectomy specimen after NAC, and the concordance rate will be the primary endpoint.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. New case of muscle-invasive bladder cancer
2. Tumors of sufficient amount of transurethral resection
3. Patients who receive neoadjuvant platinum-based chemotherapy
4. Patients who receive radical cystectomy
5. Patients with available clinical and pathological information
6. Patients who consented.
Key exclusion criteria
Patients who are not appropriate to enter the clinical study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | TAKAHIRO |
| Middle name | |
| Last name | INOUE |
Organization
Mie University Graduate School of Medicine
Division name
Nephro-Urologic Surgery and Andrology
Zip code
514-8507
Address
2-174 Edobashi Tsu Mie
TEL
0592315026
tinoue28@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sugino |
Organization
Mie University Graduate School of Medicine
Division name
Nephro-Urologic Surgery and Andrology
Zip code
514-8507
Address
2-174 Edobasih Tsu Mie
TEL
0592315026
Homepage URL
tinoue28@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobasih Tsu Mie
Tel
059-231-5045
kk-sien@med.mie-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient information
Bladder cancer pathological information
Zebrafish xenograft successful rate
others
Management information
Registered date
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060702
