UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054315 |
|---|---|
| Receipt number | R000062045 |
| Scientific Title | Multicenter retrospective study of the Efficacy of Adjuvant Immunotherapy after Radical therapy (Surgery or Radiotherapy) for Urothelial Carcinoma (Michinoku Study 1015) |
| Date of disclosure of the study information | 2024/05/07 |
| Last modified on | 2024/05/04 07:35:56 |
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Basic information
Public title
Multicenter retrospective study of the Efficacy of Adjuvant Immunotherapy after Radical therapy (Surgery or Radiotherapy) for Urothelial Carcinoma (Michinoku Study 1015)
Acronym
Multicenter retrospective study of the Efficacy of Adjuvant Immunotherapy after Radical therapy for Urothelial Carcinoma (Michinoku Study 1015)
Scientific Title
Multicenter retrospective study of the Efficacy of Adjuvant Immunotherapy after Radical therapy (Surgery or Radiotherapy) for Urothelial Carcinoma (Michinoku Study 1015)
Scientific Title:Acronym
Multicenter retrospective study of the Efficacy of Adjuvant Immunotherapy after Radical therapy for Urothelial Carcinoma (Michinoku Study 1015)
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
With the development of new drugs through large-scale trials, the environment surrounding clinical practice, including molecular-targeted drugs and immunotherapy, is changing daily, creating a major paradigm shift. However, randomized controlled trials may not reflect actual clinical practice, and it is necessary to verify whether the effects of clinical trials can be obtained in the same way in actual clinical practice. The purpose of this project is to investigate the efficacy of immunotherapy after local treatment based on existing data (clinical information) of patients who underwent surgery and radiation therapy for urothelial carcinoma (bladder cancer, renal pelvis ureter cancer, etc.).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy (progression-free survival, cancer-specific survival, and overall survival) of immunotherapy after local treatment for urothelial carcinoma (bladder cancer, pyelonephritis) will be compared with that of no treatment or chemotherapy after local treatment. Overall analysis as well as analysis by cancer site and intervention method will be performed.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients between 18 and 100 years of age, with a pathologic diagnosis of urothelial carcinoma of the urethra, who have undergone total cystectomy, total nephroureterectomy, or local radiation therapy. Urothelial carcinoma is included in urothelial carcinoma.
Period of case collection: January 2005 - March 31, 2031.
Key exclusion criteria
Patients with urothelial carcinoma (bladder cancer, cancer of the renal pelvis and ureter) for which treatment intervention is unknown, patients for whom important outcomes (recurrence, death, date of last confirmed survival, etc.) are unknown, patients who cannot be followed for observation periods of less than 3 months, etc., and patients who have indicated refusal to participate.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University
Division name
Urology
Zip code
0368562
Address
5 Zaifu-cho, Hirosaki-shi, Aomori
TEL
0172-39-5091
shingoh@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University
Division name
Urology
Zip code
0368562
Address
5 Zaifu-cho, Hirosaki-shi, Aomori
TEL
0172-39-5091
Homepage URL
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
None
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
Hirosaki University Graduate School of medicine
Address
5 Zaifu-cho, Hirosaki-shi, Aomori
Tel
0172395091
shingoh@hirosaki-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 | 07 | 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
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2031 | Year | 03 | Month | 31 | Day |
Other
Other related information
Facilities for the Provision of Existing Data: Current Facilities 10 Facilities
Hirosaki University Graduate School of Medicine Lecture on Urological Sciences
Lecture on Urologic Science at Iwate Medical University,
Lecture on Kidney Urology at Akita University Graduate School of Medicine,
Tohoku University Graduate School of Medicine, Department of Surgical Pathology, Urological Sciences Division,
Miyagi Prefectural Garn Center, Department of Urology,
Department of Urology, Tohoku Medical and Pharmaceutical University,
Yamagata University Graduate School of Medicine, Department of Nephrology Lecture,
Fukushima Prefectural University of Medicine, Department of Urology,
Department of Clinical Medicine, Faculty of Medicine, University of Tsukuba, Department of Nephrouretic Surgery,
Department of Renal Urological Surgery, Faculty of Medicine, International University of Medical and Welfare.
Management information
Registered date
| 2024 | Year | 05 | Month | 04 | Day |
Last modified on
| 2024 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062045
