UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037308 |
|---|---|
| Receipt number | R000042339 |
| Scientific Title | Observational, prospective study to examine association values of Interferon-Gamma Release Assay (IGRA) before and after treatment and clinical response or adverse events in patients with lung cancer who received cytotoxic cancer chemotherapy containing platinum with or without Immune Checkpoint Inhibitor (ICI) |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2023/08/01 20:46:28 |
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Basic information
Public title
Observational, prospective study to examine association values of Interferon-Gamma Release Assay (IGRA) before and after treatment and clinical response or adverse events in patients with lung cancer who received cytotoxic cancer chemotherapy containing platinum with or without Immune Checkpoint Inhibitor (ICI)
Acronym
Observational, prospective study to examine association values of Interferon-Gamma Release Assay (IGRA) before and after treatment and clinical response or adverse events in patients with lung cancer who received cytotoxic cancer chemotherapy containing platinum with or without Immune Checkpoint Inhibitor (ICI)
Scientific Title
Observational, prospective study to examine association values of Interferon-Gamma Release Assay (IGRA) before and after treatment and clinical response or adverse events in patients with lung cancer who received cytotoxic cancer chemotherapy containing platinum with or without Immune Checkpoint Inhibitor (ICI)
Scientific Title:Acronym
Observational, prospective study to examine association values of Interferon-Gamma Release Assay (IGRA) before and after treatment and clinical response or adverse events in patients with lung cancer who received cytotoxic cancer chemotherapy containing platinum with or without Immune Checkpoint Inhibitor (ICI)
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine association values of Interferon-Gamma Release Assay (IGRA) before and after treatment and clinical response or adverse events in patients with lung cancer who received cytotoxic cancer chemotherapy containing platinum with or without Immune Checkpoint Inhibitor (ICI)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between values of Interferon-Gamma Release Assay and immune related adverse events or efficacy in patients treated with cytotoxic chemotherapy with or without immune checkpoint inhibitor
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
1.Patient who received ICI plus chemotherapyor platinum doublet alone as first-line regimen. But, molecular targeted therapy alone and monotherapy of immune checkpoint inhibitor are permitted as prior treatment.
2. Patient with recurrence lung cancer or unresectable progression caner.
3.Diagnosis of small cell lung cancer or the non-small-cell lung cancer
4.Patient was 20 years oldor morehe at registration.
5. Patient with Performance Status 0-2.
5. Patient with the evaluable lesion.
6. Written informed consent was obtained from the patient
Key exclusion criteria
1 Patient with synchronou or metachronous lung cancer
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | HIdekazu |
| Middle name | |
| Last name | Suzuki |
Organization
Osaka Prefectural Hospital Organization
Osaka Habikino Medical Center
Division name
Thoracic Oncology
Zip code
583-8588
Address
1-3-7,Habikino, Habikino-City, Osaka
TEL
0729572121
suzukih@ra.opho.jp
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Suzuki |
Organization
Department of Thoracic Oncology, Osaka Habikinol Medical Center
Division name
Thoracic Oncology
Zip code
583-8588
Address
1-3-7,Habikino, Habikino-City, Osaka
TEL
0729572121
Homepage URL
suzukih@ra.opho.jp
Sponsor or person
Institute
Osaka Prefectural Hospital Organization
Osaka Habikino Medical Center
Institute
Department
Personal name
Funding Source
Organization
Osaka Prefectural Hospital Organization
Osaka Habikino Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Prefectural Hospital Organization Osaka Habikino Medical Center
Address
3-7-1 Habikino Habikino-City, Osaka
Tel
0729572121
okuday@opho.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
| 2019 | Year | 07 | Month | 10 | 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
46
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine association values of Interferon-Gamma Releasing Assay before and after treatment and clinical response or adverse events in patients with lung cancer who received cytotoxic cancer chemotherapy containing platinum with or without Immune Checkpoint Inhibitor
Management information
Registered date
| 2019 | Year | 07 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042339
