UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049324 |
|---|---|
| Receipt number | R000056171 |
| Scientific Title | A pilot study on predictors of severe radiation pneumonitis by Breathomics |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2024/04/29 07:02:33 |
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Basic information
Public title
A pilot study on predictors of severe radiation pneumonitis by Breathomics
Acronym
Breathomics for severe radiation pneumonitis
Scientific Title
A pilot study on predictors of severe radiation pneumonitis by Breathomics
Scientific Title:Acronym
Breathomics for severe radiation pneumonitis
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comprehensive analysis of metabolites in exhaled breath before and during treatment in non-small cell lung cancer patients who are inoperable or rejected and scheduled for definitive chemoradiotherapy to predict radiation pneumonitis.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radiation pneumonitis severity (Grade 0-1 vs. Grade 2 or higher)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Non-small lung cancer
2) stage IIIA-C
3)planning definitive chemoradiotherapy
4)case with written informed consent.
Key exclusion criteria
1)Cases with contralateral hilar lymph node metastasis
2)Cases without contrast-enhanced CT or FDG-PET
3)planning radiotherapy alone
4)Cases with a history of radiotherapy to the chest
5)Cases with clear interstitial pneumonia or active infectious pneumonia
6)Cases with other active malignancy
7)Cases judged to be ineligible by the principal investigator or co-investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Jingu |
Organization
Tohoku University Graduate School of Medicine
Division name
Depart of Radiation Oncology
Zip code
980-8574
Address
1-1 Seiryou-chou, Aobaku
TEL
0227177312
kjingurad@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Jingu |
Organization
Tohoku University Graduate School of Medicine
Division name
Depart of Radiation Oncology
Zip code
9808574
Address
1-1 Seiryou-chou, Aobaku
TEL
0227177312
Homepage URL
kjingurad@yahoo.co.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Treatment is standard treatment according to clinical guidelines. Among them, exhaled metabolites are collected twice, before the start of radiation therapy and at a time when the total is 30-40 Gy. Post-treatment follow-up will be carried out at regular hospital visits as usual, and diagnostic imaging and blood sampling will be carried out as appropriate.
Management information
Registered date
| 2022 | Year | 10 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056171
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
