UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037617 |
|---|---|
| Receipt number | R000042871 |
| Scientific Title | Research on radiation therapy for prostate ductal carcinoma and small cell carcinoma |
| Date of disclosure of the study information | 2019/08/07 |
| Last modified on | 2022/02/07 10:12:51 |
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Basic information
Public title
Research on radiation therapy for prostate ductal carcinoma and small cell carcinoma
Acronym
Research on radiation therapy for prostate ductal carcinoma and small cell carcinoma
Scientific Title
Research on radiation therapy for prostate ductal carcinoma and small cell carcinoma
Scientific Title:Acronym
Research on radiation therapy for prostate ductal carcinoma and small cell carcinoma
Region
| Japan |
Condition
Condition
prostate ductal carcinoma and small cell carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analyze the therapeutic results and adverse events of radiation therapy for prostate ductal carcinoma and small cell carcinoma, and investigate the actual clinical situation.
Basic objectives2
Others
Basic objectives -Others
Survey of treatment status
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival after initiation of radiation therapy
Key secondary outcomes
Adverse events from radiation therapy
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
Key inclusion criteria
1) Patients diagnosed pathologically as prostate ductal carcinoma and small cell carcinoma
2) Patients who received radiation therapy from January 1996 to December 2018
Key exclusion criteria
1) Patients who cannot obtain consent for participation in this study
2) Patients who are judged to be inappropriate as a target by the doctor's judgment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsumasa |
| Middle name | |
| Last name | Nakamura |
Organization
Hamamatsu University Hospital
Division name
Radiology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2111
nakam@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Kawamura |
Organization
Gunma University Hospital
Division name
Radiation Oncology
Zip code
371-8511
Address
3-39-15 Showamachi, Maebashi, Gunma
TEL
027-220-8391
Homepage URL
kawa@gunma-u.ac.jp
Sponsor or person
Institute
Japanese Radiation Oncology Study Group
Institute
Department
Personal name
Funding Source
Organization
Japanese Radiation Oncology Study Group
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
Gunma University Hospital IRB
Address
3-39-15 Showamachi, Maebashi, Gunma
Tel
027-220-8740
kawa@gunma-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
| 2019 | Year | 08 | 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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-institutional retrospective research
Management information
Registered date
| 2019 | Year | 08 | Month | 07 | Day |
Last modified on
| 2022 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042871
