UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031881 |
|---|---|
| Receipt number | R000036351 |
| Scientific Title | Clinical Significance of Monitoring by Interferon-Gamma Releasing Assay (IGRA) in Patients with Non-Small Cell Lung Cancer receiving Checkpoint Inhibitor Treatment |
| Date of disclosure of the study information | 2018/03/24 |
| Last modified on | 2022/10/04 15:38:46 |
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Basic information
Public title
Clinical Significance of Monitoring by Interferon-Gamma Releasing Assay (IGRA) in Patients with Non-Small Cell Lung Cancer receiving Checkpoint Inhibitor Treatment
Acronym
Clinical Significance of Monitoring by Interferon-Gamma Releasing Assay (IGRA) in Checkpoint Inhibitor Treatment
Scientific Title
Clinical Significance of Monitoring by Interferon-Gamma Releasing Assay (IGRA) in Patients with Non-Small Cell Lung Cancer receiving Checkpoint Inhibitor Treatment
Scientific Title:Acronym
Clinical Significance of Monitoring by Interferon-Gamma Releasing Assay (IGRA) in Checkpoint Inhibitor Treatment
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Examine between Clinical Outcomes and Interferon-Gamma (IFN-gamma) measured by IGRA in Patients with Non-Small Cell Lung Cancer receiving Immune Checkpoint Inhibitor (ICI) Treatment: Observational prospective study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between IFN-gamm and efficacy, immune-related adverse events, or Hyper progressive Disease in Patients with Non-Small Cell Lung Cancer receiving ICI
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.Unresectable or progressive non-small cell lung Cancer patient treated with ICI alone regardless of the number of the previous regimens.
2.Twenty years old or older patient at registration.
3. Patients with performance status 0-2.
4. Patients with the measurable lesion.
5. Written Informed Consent from the patient
Key exclusion criteria
1.Patient with an active heterochronous or synchronous overlap cancer (carcinoma-insitu or cured intramucosal canceris excluded from overlap cancer)
2 Patient with active liver disease (ex. HBV-DNA positive, autoimmune hepatitis, anliver cirrhosis).
3 Female patient with the possibility (intention) of the pregnancy.
Patient whom the Doctor in charge judged to be inappropriate as an object of this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Suzuki |
Organization
Osaka Habikino Medical Center
Division name
Thoracic Oncology
Zip code
583-8588
Address
3-7-1 Habikino, Habikino City, Osaka , Japan
TEL
+81-72-957-2121
suzukih@ra.opho.jp
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Suzuki |
Organization
Osaka Habikino Medical Center
Division name
Thoracic Oncology
Zip code
583-8588
Address
3-7-1 Habikino, Habikino City, Osaka , Japan
TEL
+81-72-957-2121
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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Habikino Medical Center
Address
3-7-1 Habikino, Habikino City, Osaka , Japan
Tel
+81-72-957-2121
kokyucen@ra.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
| 2018 | Year | 03 | Month | 24 | 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
30
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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2018 | Year | 03 | Month | 24 | Day |
Last modified on
| 2022 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036351
