UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050523 |
|---|---|
| Receipt number | R000057537 |
| Scientific Title | Risk factors for the development and severity of interstitial lung disease associated with EGFR tyrosine kinase inhibitors in non-small cell lung cancer: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/03/13 |
| Last modified on | 2023/03/13 19:52:46 |
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Basic information
Public title
Risk factors for the development and severity of interstitial lung disease associated with EGFR tyrosine kinase inhibitors in non-small cell lung cancer: a systematic review and meta-analysis
Acronym
Risk factors for the development and severity of interstitial lung disease associated with EGFR tyrosine kinase inhibitors in non-small cell lung cancer: a systematic review and meta-analysis
Scientific Title
Risk factors for the development and severity of interstitial lung disease associated with EGFR tyrosine kinase inhibitors in non-small cell lung cancer: a systematic review and meta-analysis
Scientific Title:Acronym
Risk factors for the development and severity of interstitial lung disease associated with EGFR tyrosine kinase inhibitors in non-small cell lung cancer: a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
EGFR tyrosine kinase inhibitor-associated interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify risk factors for the development and severity of interstitial lung disease associated with EGFR tyrosine kinase inhibitors in non-small cell lung cancer
Basic objectives2
Others
Basic objectives -Others
This study aims to identify risk factors for the development and severity of interstitial lung disease associated with EGFR tyrosine kinase inhibitors in non-small cell lung cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors for the severity of interstitial lung disease
Key secondary outcomes
Risk factors for the development of interstitial lung disease
Base
Study type
Others,meta-analysis etc
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
This systematic review will target participants as follows: Adult patients with histopathologically diagnosed non-small cell lung cancer with an EGFR mutation who have developed EGFR tyrosine kinase inhibitor-associated interstitial lung disease. EGFR tyrosine kinase inhibitor-associated interstitial lung disease is defined as any lung injury that occurred while using an EGFR tyrosine kinase inhibitor that the clinician judged overall to be drug-related. EGFR tyrosine kinase inhibitors include gefitinib, erlotinib, afatinib, dacomitinib, and osimertinib.
Key exclusion criteria
Pediatric patients under 18 years of age
Adult patients with histopathologically diagnosed small-cell lung cancer
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Fukuda |
Organization
Showa University, School of Medicine
Division name
Department of Medicine, Division of Respiratory Medicine and Allergology
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
+81-3-3784-8532
y.f.0423@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Fukuda |
Organization
Showa University, School of Medicine
Division name
Department of Medicine, Division of Respiratory Medicine and Allergology
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
+81-3-3784-8532
Homepage URL
y.f.0423@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-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
| 2023 | Year | 03 | Month | 13 | 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
| 2023 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. A systematic search of the literature will be conducted according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) Statement. We will search the following electrical databases; the Cochrane Central Resister of Controlled Trials (CENTRAL); MEDLINE via Ovid. Additionally, we will also search the other resources; the World health Organization International Clinical Trials Platform Search Portal (ICTRP) and ClinicalTrials.gov.
2. Meta-analysis will be performed using statistical software, such as Review Manager 5.3.5, R, and STATA.
3. To assess the risk of bias, we will use the Risk of Bias 1 tool for RCTs and Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) for non-RCT/ Observational studies. Two reviewers will independently screen the full text of each study and decide whether the studies met the inclusion criteria. Any disagreement will be resolved by discussion or consulting the third reviewer. We will assess heterogeneity by using the I2 statistical method and publication bias using funnel plot.
4. Sensitivity analysis and subgroup analysis will be performed as needed based on the results of the adopted literature.
5. Forest plots will be created for risk factors for the development and severity of interstitial lung disease associated with EGFR tyrosine kinase inhibitors in non-small cell lung cancer.
Management information
Registered date
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057537
