UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042962 |
|---|---|
| Receipt number | R000049046 |
| Scientific Title | A prospective observational study of immune-related adverse events, treatment efficacy, and pre-existing autoantibodies in patients with small-cell lung cancer who was treated by immune checkpoint inhibitor |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2023/07/31 01:50:20 |
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Basic information
Public title
A prospective observational study of immune-related adverse events, treatment efficacy, and pre-existing autoantibodies in patients with small-cell lung cancer who was treated by immune checkpoint inhibitor
Acronym
Pre-existing autoantibodies and irAE in SCLC patients treated with ICI
Scientific Title
A prospective observational study of immune-related adverse events, treatment efficacy, and pre-existing autoantibodies in patients with small-cell lung cancer who was treated by immune checkpoint inhibitor
Scientific Title:Acronym
Pre-existing autoantibodies and irAE in SCLC patients treated with ICI
Region
| Japan |
Condition
Condition
Patients with small cell lung cancer who was treated by chemotherapy plus immune checkpoint inhibitor as first line therapy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between preexisting autoantibodies and immune-related adverse events and treatment efficacy in patients with advanced small-cell lung cancer prospectively
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of immune-related adverse events
Key secondary outcomes
The incidence of paraneoplastic syndrome
Progression free survival
Overall survival
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
Patients diagnosed as small-cell lung cancer, who was treated by chemotherapy plus immune checkpoint inhibitor
Patients over 20 years old
Patients who provided written informed consent before enrolment
Key exclusion criteria
Patients who were determined as unsuitable by attending physician
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sato |
Organization
Kobe City Medical Center General Hospital
Division name
Respiratory Medicine
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL
0783024321
yuki_sato@kcho.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sato |
Organization
Kobe City Medical Center General Hospital
Division name
Respiratory Medicine
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL
0783024321
Homepage URL
yuki_sato@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe City Medical Center General Hospital
Respiratory Medicine
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 City Medical Center General Hospital, CCRI
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan
Tel
0783024321
ctc-kobe@kcho.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
神戸低侵襲がん医療センター
神戸市立医療センター西市民病院
神戸市立西神戸医療センター
神鋼記念病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | 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
54
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
Main results already published
Date of protocol fixation
| 2019 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2021 | Year | 01 | Month | 10 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049046
| 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 |
