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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048041
Receipt No. R000054760
Scientific Title Usefulness of Bladder Volume Real-Time Monitoring System in Pelvic Image-Induced Radiation Therapy
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/21

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Basic information
Public title Usefulness of Bladder Volume Real-Time Monitoring System in Pelvic Image-Induced Radiation Therapy
Acronym Dfree
Scientific Title Usefulness of Bladder Volume Real-Time Monitoring System in Pelvic Image-Induced Radiation Therapy
Scientific Title:Acronym Dfree
Region
Japan

Condition
Condition Patients receiving radiation therapy under bladder volume control
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Improving the efficiency of high-precision radiation therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Volume difference between treatment plan CT and kVCT bladder volume at the time of treatment
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Since the bladder dose volume, urinary intention awareness intensity, residual urine increase rate, etc. differ for each case, all trials of the D method, the on-time standby method, and the self-report method are all performed and assigned in the same case. In the case of intensity-modulated radiation therapy for prostate cancer of one person, where 35 ~ 40 treatments are required, the D method (2 times), the regular waiting method (2 times), and the self-report method (1 time) are performed each week on the day of radiation therapy 5 times a week.
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 Patients receiving radiation therapy under bladder volume control
2 Patients who can measure by Dfree
3 Patients with possible urinary abstinence and self-urination
Key exclusion criteria 1 Patients with anuria and oliguria.
2 Patients who have difficulty communicating with the patient
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Ohno
Organization Kamagaya General Hospital
Division name Radiation therapy
Zip code 273-0121
Address 929-6 Hatsutomi, Kamagaya-City Chiba
TEL 047-498-8111
Email chiken@kamagaya-hp.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Ohno
Organization Kamagaya General Hospital
Division name Radiation therapy
Zip code 273-0121
Address 929-6 Hatsutomi, Kamagaya-City Chiba
TEL 047-498-8111
Homepage URL
Email chiken@kamagaya-hp.jp

Sponsor
Institute Kamagaya General Hospital
Institute
Department

Funding Source
Organization Kamagaya General Hospital
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 The TOKUSHUKAI GROUP ETHICS COMMITTEE
Address Emina Building 3F, 1-8-7 Koji-machi, Chiyoda-ku, Tokyo
Tel 03-3263-4801
Email mirai-ec4@mirai-iryo.com

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
2022 Year 08 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 Open public recruiting
Date of protocol fixation
2022 Year 05 Month 25 Day
Date of IRB
2022 Year 07 Month 13 Day
Anticipated trial start date
2022 Year 07 Month 13 Day
Last follow-up date
2024 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 13 Day
Last modified on
2022 Year 07 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054760

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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