UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046895 |
|---|---|
| Receipt number | R000053506 |
| Scientific Title | Drug-induced lung injury in patients with anti-EGFR antibody and ICI |
| Date of disclosure of the study information | 2022/02/13 |
| Last modified on | 2024/02/16 18:26:30 |
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Basic information
Public title
Analysis of drug-induced lung injury in patients with anti-EGFR antibody and ICI
Acronym
DILI in patients with anti-EGFR antibody and ICI
Scientific Title
Drug-induced lung injury in patients with anti-EGFR antibody and ICI
Scientific Title:Acronym
DILI in patients with anti-EGFR antibody and ICI
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Pneumology | Oto-rhino-laryngology | Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Incidence of pneumonitis
Basic objectives2
Others
Basic objectives -Others
Factors for DILI
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of DILI
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
Head and neck cancers who were treated with anti-EGFR antibody and/or ICI
Key exclusion criteria
Patients without CT findings
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Takiguchi |
Organization
Chiba University
Division name
Medical Oncology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba City
TEL
043-222-7171
takiguchi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Arai |
Organization
T.W.Y.C.
Division name
Chemotherapy
Zip code
276-8524
Address
477-96 Owadashinden, Yachiyo City, Chiba
TEL
047-450-6000
Homepage URL
arai.makoto@twmu.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Univeristy
Address
1-8-1 Inohana, Chuo-ku, Chiba City
Tel
043-222-7171
araim-cib@umin.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
| 2022 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37274471/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37274471/
Number of participants that the trial has enrolled
150
Results
DLI is seen frequently in patients receiving sequential PD-1 inhibitor and anti-EGFR antibody therapy.
Results date posted
| 2024 | Year | 02 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://pubmed.ncbi.nlm.nih.gov/37274471/
Participant flow
https://pubmed.ncbi.nlm.nih.gov/37274471/
Adverse events
https://pubmed.ncbi.nlm.nih.gov/37274471/
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/37274471/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
By surveying their medical records retrospectively, the patients were selected and evaluated.
Management information
Registered date
| 2022 | Year | 02 | Month | 13 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053506
