UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025904 |
|---|---|
| Receipt number | R000029769 |
| Scientific Title | OSL dosimetry for dose verification of organs at risk in high-dose-rate brachytherapy |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/08/03 19:09:51 |
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Basic information
Public title
OSL dosimetry for dose verification of organs at risk in high-dose-rate brachytherapy
Acronym
OSL dosimetry in high-dose-rate brachytherapy
Scientific Title
OSL dosimetry for dose verification of organs at risk in high-dose-rate brachytherapy
Scientific Title:Acronym
OSL dosimetry in high-dose-rate brachytherapy
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of OSL dosimetry
Basic objectives2
Others
Basic objectives -Others
Verification of OSL dosimetry
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Precision of dosimetry
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
dosimetry during intra-cavitary brachytherapy
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
Female
Key inclusion criteria
Patients with cervical cancer who undergo intra-cavitary brachytherapy for cervical cancer
Key exclusion criteria
Unremarkable
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Ikushima |
Organization
Tokushima University Graduate School
Division name
Institute of Biomedical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho
TEL
088-633-9051
ikushima@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Hitoshi |
Organization
Tokushima University Graduate School
Division name
Institute of Biomedical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho
TEL
088-633-9051
Homepage URL
ikushima@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
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
Tokushima University
Address
Kuramoto Cho 3-18-15, Tokushima City
Tel
088-633-9051
ikushima@tokushima-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
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f3.cgi
Number of participants that the trial has enrolled
21
Results
A dose calibration curve was obtained in the range of 0.1 Gy to 10.0 Gy. Although doses at each analytical position were varied depending on the angle of the dosimeter, the average value of the three analytical positions showed good responses. Then, we evaluated that our dosimeter can measure rectum dose within the accuracy of 10% (k=3).
Results date posted
| 2020 | Year | 08 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
cervical cancer patients who underwent brachytherapy
Participant flow
The patients were registered with consent just before initiation of radiation therapy
Adverse events
No patient developed an adverse event
Outcome measures
Dose measurement accuracy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 30 | Day |
Last modified on
| 2020 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029769
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/08/03 | 20実施計画書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/08/03 | 症例データ仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/08/03 | 研究症例データ.docx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/29769
