UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045753 |
|---|---|
| Receipt number | R000052236 |
| Scientific Title | Study of transurethral resection of bladder tumor in one-piece using flexible cystoscope. |
| Date of disclosure of the study information | 2021/10/20 |
| Last modified on | 2024/10/16 17:34:14 |
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Basic information
Public title
Study of transurethral resection of bladder tumor in one-piece using flexible cystoscope.
Acronym
Study of transurethral resection of bladder tumor in one-piece using flexible cystoscope.
Scientific Title
Study of transurethral resection of bladder tumor in one-piece using flexible cystoscope.
Scientific Title:Acronym
Study of transurethral resection of bladder tumor in one-piece using flexible cystoscope.
Region
| Japan |
Condition
Condition
Bladder tumor
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Transurethral Resection of Bladder Tumor (TURBT) is the standard treatment for bladder tumors. In most cases, the tumor is resected using a loop-type electrode, but the tumors resected fragmentally and pathological evaluation is difficult. In this study, we investigated the efficacy of transurethral resection of bladder tumor in one-piece using snare.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological evaluation of ESRBT specimens
Key secondary outcomes
Adverse event rate, operative time, muscle layer sampling rate, degree of thermal degeneration or destruction of tissue
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Tumour resection with a snare is performed on eligible patients.ESR biopsy, cold cup biopsy and TUR biopsy are performed in patients who meet the indicated criteria and for whom random biopsy is recommended.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 years of age or older
2) ECOG Performance Status 0-2
3) No other active multiple cancers (including hematological malignancies).
4) The patient has been informed of the disease, and written consent for participation in this study with his or her own will.
5) Less than 10 mm transverse to the tumor base and less than 3 tumors in the bladder.
6) Suspected intermediate or high risk on preoperative examination and scheduled for random biopsy for diagnostic purposes.
7) Patients with positive urine cytology without intravesical tumors and scheduled for random biopsy for diagnostic purposes.
Patients must meet all of the criteria in 1) to 4) and one of the criteria in 5) to 7) for enrollment.
Key exclusion criteria
1) Patients with poorly controlled infections (including active tuberculosis).
2) Patients with serious complications (malignant hypertension, severe congestive heart failure, severe coronary insufficiency, myocardial infarction within 3 months, end-stage liver cirrhosis, poorly controlled diabetes, severe pulmonary fibrosis, active interstitial pneumonia, etc.).
3) Patients in an immunocompromised state due to disease or treatment.
4) Patients with severe mental disorders.
5) Patients who are participating in other clinical studies (including clinical trials).
6) Patients who are pregnant or lactating mothers.
7) Patients who are deemed unsuitable by the principal investigator or sub-investigator due to medical, psychological or other factors.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Matsukawa |
Organization
University of Jikei Kashiwa hospital
Division name
Department of Urology
Zip code
277-8567
Address
163-1, Kashiwashita, Kashiwa-shi, Chiba
TEL
04-7164-1111
a.matsu.audi1055g@gmail.com
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Matsukawa |
Organization
University of Jikei Kashiwa hospital
Division name
Department of Urology
Zip code
277-8567
Address
163-1, Kashiwashita, Kashiwa-shi, Chiba
TEL
04-7164-1111
Homepage URL
a.matsu.audi1055g@gmail.com
Sponsor or person
Institute
University of Jikei Kashiwa hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Tokyo Jikei University
Address
3-25-8, nishishinbashi, minatoku, Tokyo
Tel
03-3433-1111
rinri@jikei.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
| 2021 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052236
