UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044552 |
|---|---|
| Receipt number | R000050326 |
| Scientific Title | An observational study on the probability of pneumonitis in immune-checkpoint inhibitors plus chemotherapy for extensive-stage small cell lung cancer |
| Date of disclosure of the study information | 2021/07/15 |
| Last modified on | 2023/06/19 07:28:26 |
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Basic information
Public title
An observational study on the probability of pneumonitis in immune-checkpoint inhibitors plus chemotherapy for extensive-stage small cell lung cancer
Acronym
Pneumonitis in immune-checkpoint inhibitors plus chemotherapy for extensive-stage small cell lung cancer
Scientific Title
An observational study on the probability of pneumonitis in immune-checkpoint inhibitors plus chemotherapy for extensive-stage small cell lung cancer
Scientific Title:Acronym
Pneumonitis in immune-checkpoint inhibitors plus chemotherapy for extensive-stage small cell lung cancer
Region
| Japan |
Condition
Condition
Extensive-stage small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of drug-induced lung injury in immune checkpoint inhibitors plus chemotherapy given for extensive-stage small cell lung cancer in clinical practice.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of drug-induced lung injury
Key secondary outcomes
Efficacy endpoints
1.Response rate
2.Rate of disease control
3.Progression-free survival
4.Overall survival
Safety endpoints
1.Severity of pneumonitis
2.Time to onset of pneumonitis
3.Incidence of lung injury with and without interstitial abnormality
4.Incidence and severity of immune-related adverse events other than pneumonitis
5.Incidence of serious adverse events
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 whose medical information can be obtained from the medical record
2.Patients with extensive-stage or recurrent small cell lung cancer after surgery or chemoradiotherapy
3.Patients who have received at least one course of immune checkpoint inhibitors plus chemotherapy
Key exclusion criteria
Patients who have requested not to participate in this study based on published information
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Tachihara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
6500017
Address
7-5-1. Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
0783825660
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Katsurada |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
6500017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
0783825660
Homepage URL
nk1208@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Kobe university hospital clinical & translational research center
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-382-6669
kansatsu@med.kobe-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
| 2021 | Year | 07 | Month | 15 | 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
70
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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient's characteristics, presence of interstitial abnormality, date of start and date of discontinuation of immune checkpoint inhibitor plus chemotherapy, presence of discontinuation, reason for discontinuation, number of courses administered, response, presence of disease progression, date of disease progression, presence and date of onset of lung injury, severity of lung injury, other serious adverse events
Management information
Registered date
| 2021 | Year | 06 | Month | 15 | Day |
Last modified on
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050326
| 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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