UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054713 |
|---|---|
| Receipt number | R000062524 |
| Scientific Title | Prospective observational study to investigate serum interleukin-6 levels prior to immune checkpoint inhibitor treatment and the occurrence of immune-related adverse events with immune checkpoint inhibitors for non-small cell lung cancer. |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/12/21 09:41:42 |
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Basic information
Public title
Prospective observational study to investigate serum interleukin-6 levels prior to immune checkpoint inhibitor treatment and the occurrence of immune-related adverse events with immune checkpoint inhibitors for non-small cell lung cancer.
Acronym
IL-6 and immune-related adverse events in patients with non-small cell lung cancer.
Scientific Title
Prospective observational study to investigate serum interleukin-6 levels prior to immune checkpoint inhibitor treatment and the occurrence of immune-related adverse events with immune checkpoint inhibitors for non-small cell lung cancer.
Scientific Title:Acronym
IL-6 and immune-related adverse events in patients with non-small cell lung cancer.
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate serum IL-6 levels and the occurrence of immune-related adverse events with immune checkpoint inhibitor treatment in patients with advanced non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of immune-related adverse events.
Key secondary outcomes
Efficacy (1-year PFS, ORR) and prognosis (1-year OS) of immune checkpoint inhibitors
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 aged 20 years and over
2) Patients capable of giving written consent
3) Patients with negative therapeutic target driver gene mutations/translocations
4) Patients who plan to use immune checkpoint inhibitors as first-line therapy
Key exclusion criteria
1) Patients previously treated with immune checkpoint inhibitors
2) Patients with a history of treatment with cytotoxic anticancer drugs within 6 months
3) Patients with positive driver gene mutations/translocations
4) Patients with coexisting autoimmune diseases
5) Patients with active infections
6) Patients with an estimated prognosis of less than 2 months
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Tamura |
Organization
NHO Iwakuni Clinical Center
Division name
Respiratory Medicine
Zip code
740-8510740-8510
Address
1-1-1 Atago-machi, Iwakuni-shi, Yamaguchi
TEL
0827-34-1000
tomoki19830211@gmail.com
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Tamura |
Organization
NHO Iwakuni Clinical Center
Division name
Respiratory Medicine
Zip code
740-8510
Address
1-1-1 Atago-machi, Iwakuni-shi, Yamaguchi
TEL
0827-34-1000
Homepage URL
tomoki19830211@gmail.com
Sponsor or person
Institute
NHO Iwakuni Clinical Center
Institute
Department
Personal name
TOMOKI TAMURA
Funding Source
Organization
NHO Iwakuni Clinical Center
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
NHO Iwakuni Clinical Center
Address
1-1-1 Atago-machi, Iwakuni-shi, Yamaguchi
Tel
0827-34-1000
tomoki19830211@gmail.com
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
| 2024 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observations include.
Patient characteristics: age, gender, smoking history, histology, stage, PD-L1 expression, presence of driver gene abnormalities, concomitant diseases, PS, concomitant medications
Imaging studies: chest X-ray, CT scan, MRI scan
Blood tests: peripheral blood tests, biochemical tests, coagulation tests, tumour markers
Cancer drug therapy: type of immune checkpoint inhibitors and cytotoxic anticancer drugs administered, their dosage and duration, supportive care,
Adverse events: names of immune-related adverse events, dates of onset and severity of adverse events.
Survival: survival and death, date of last ascertainment, whether the immune checkpoint inhibitor was continued or not, and if the immune checkpoint inhibitor was discontinued, the date and reason for discontinuation.
Management information
Registered date
| 2024 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062524
