UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036441 |
|---|---|
| Receipt number | R000041101 |
| Scientific Title | A prospective observational study to evaluate the effect of the dose rate on infectious/non-infectious pneumonitis and pulmonary toxicities in patients who receive total body irradiation (TBI) prior to allogeneic hematopoietic stem cell transplantations |
| Date of disclosure of the study information | 2019/04/08 |
| Last modified on | 2019/04/08 14:55:45 |
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Basic information
Public title
A prospective observational study to evaluate the effect of the dose rate on infectious/non-infectious pneumonitis and pulmonary toxicities in patients who receive total body irradiation (TBI) prior to allogeneic hematopoietic stem cell transplantations
Acronym
The effect of dose rate in TBI on pulmonary toxicities after allo-HSCT
Scientific Title
A prospective observational study to evaluate the effect of the dose rate on infectious/non-infectious pneumonitis and pulmonary toxicities in patients who receive total body irradiation (TBI) prior to allogeneic hematopoietic stem cell transplantations
Scientific Title:Acronym
The effect of dose rate in TBI on pulmonary toxicities after allo-HSCT
Region
| Japan |
Condition
Condition
AML/MDS, ALL, Malignant lymphoma, AA
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of dose rate on infectious/non-infectious pneumonitis and pulmonary toxicities in patients who receive total body radiation (TBI) prior to allogeneic hematopoietic stem cell transplantations
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of infectious/non-infectious pneumonitis and pulmonary toxicities within 1 year after transplantation
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Any patient who receives total body radiation as a conditioning therapy at Dept. Radiation Oncology and Image-Applied therapy, Kyoto University Hospital, followed by a allogeneic hematopoietic stem cell tranpslantation at Dept. Hematology and Oncology, Kyoto University Hospital.
Key exclusion criteria
Patients who disagree with this study
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Kanda |
Organization
Graduate School of Medicine,
Kyoto University
Division name
Dept. Hematology and Oncology
Zip code
606-8507
Address
shogoin-kawaharacho 54, sakyo, kyoto, kyoto, japan
TEL
075-751-3111
jkanda16@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Kanda |
Organization
Graduate School of Medicine, Kyoto University
Division name
Dept. Hematology and Oncology
Zip code
606-8507
Address
shogoin-kawaharacho 54, sakyo, kyoto, kyoto, japan
TEL
075-751-3111
Homepage URL
jkanda16@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital
Address
shogoin-kawaharacho 54, sakyo, kyoto, kyoto, japan
Tel
0757534680
ethcom@kuhp.kyoto-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 | 04 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Main endpoint: non-infectious pneumonitis within 1 year after total body iradiation using low dose rate (7-8cGy/min)
2ndary endpoint:
1. Impact of of dose rate of TBI (7-8cGy/min vs 17-21cGy/min) on following non-infectious pneumonitis within 1 year
2. Impact of total radiation dose of TBI (9-12 Gy/body vs 2-4Gy/body) on following non-infectious pneumonitis within 1 year
3. Association between dose rate or total radiation dose used in TBI and folloing infectious pneumonitis within 1 year
4. Association between dose rate or total radiation dose used in TBI and following lung toxicities within 1 year
Management information
Registered date
| 2019 | Year | 04 | Month | 08 | Day |
Last modified on
| 2019 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041101
