UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040894 |
|---|---|
| Receipt number | R000046697 |
| Scientific Title | Exploration of relationship between radiation pneumonitis and TGF-beta1 in exhaled breath condensate |
| Date of disclosure of the study information | 2020/06/25 |
| Last modified on | 2022/06/27 07:39:14 |
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Basic information
Public title
Exploration of relationship between radiation pneumonitis and TGF-beta1 in exhaled breath condensate
Acronym
Exploration of relationship between radiation pneumonitis and TGF-beta1 in exhaled breath condensate
Scientific Title
Exploration of relationship between radiation pneumonitis and TGF-beta1 in exhaled breath condensate
Scientific Title:Acronym
Exploration of relationship between radiation pneumonitis and TGF-beta1 in exhaled breath condensate
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between radiation pneumonitis and TGF-beta1 in exhaled breath condensate in patients with lung cancer received thoracic radiotherapy
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between radiation pneumonitis and TGF-beta1 in exhaled breath condensate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients receive thoracic radiotherapy for lung cancer
2) Age <= 20 years old
3) Written informed consent
Key exclusion criteria
1) Patients feel like a physical burden enrolled in this study
2) Patients feel like a mental burden enrolled in this study
3) Inappropriate patients for this study judged by physicians
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Takahashi |
Organization
Kagawa University Hospital
Division name
Department of Radiation Oncology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
takahashi.shigeo@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | Takahashi |
Organization
Kagawa University Hospital
Division name
Department of Radiation Oncology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
Homepage URL
takahashi.shigeo@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee, Kagawa University Faculty of Medicine
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel
087-898-5111
kenkyushien@kagawa-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
| 2020 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
https://iv.iiarjournals.org/content/invivo/36/3/1485.full.pdf
Publication of results
Published
Result
URL related to results and publications
https://iv.iiarjournals.org/content/invivo/36/3/1485.full.pdf
Number of participants that the trial has enrolled
10
Results
Of the seven patients with increased TGF-b1 levels in EBC 1 month after RT than before RT, five (71%) experienced G2 RP, whereas the remaining three patients with decreased TGF-b1 levels had G1 RP (p=0.083, one-sided Fisher's exact test).
Results date posted
| 2022 | Year | 06 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 10 patients were enrolled between November 2018 and October 2019. Patient characteristics are listed in Table I. Histopathology of lung cancer at the time of RT was as follows: two patients each with adenocarcinoma, squamous cell carcinoma, and relapsed adenocarcinoma; one patient each with small cell carcinoma, relapsed squamous cell carcinoma, relapsed adenosquamous cell carcinoma, and relapsed adenoid cystic carcinoma. Clinical stage according to the 8th edition of the Union for International Cancer Control at the time of RT was as follows: three patients with stage I, two with stage II, four with stage III, and one with stage IV with an isolated pulmonary metastasis relapsed after surgery.
Participant flow
This prospective study (clinical trial registration number: UMIN000040894) was approved by the Institutional Ethics Committee (approval number: H30-094). The inclusion criteria were as follows: patients who 1) received thoracic RT for lung cancer, 2) were aged >=20 years, and 3) provided written informed consent. The exclusion criteria were as follows: patients who 1) felt a physical or mental burden by enrolling in this study, and 2) considered unsuitable for this study by physicians.
Adverse events
During the 10 min for every EBC collection, no remarkable changes were observed in the patients blood pressure, pulse rate, percutaneous oxygen saturation, and general condition.
Outcome measures
In seven patients, TGF-b1 levels increased from before RT to 1 month after RT. Of the seven patients with an increase in TGF-b1 levels in EBC 1 month after RT, five (71%) experienced G2 RP, whereas the remaining three patients with decreased TGF-b1 levels had G1 RP (p=0.083, one-sided Fishers exact test) (Figure 2).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the relationship between radiation pneumonitis and TGF-beta1 in exhaled breath condensate
Management information
Registered date
| 2020 | Year | 06 | Month | 25 | Day |
Last modified on
| 2022 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046697
| Research Plan | |
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| Registered date | File name |
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