UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053613 |
|---|---|
| Receipt number | R000061182 |
| Scientific Title | Prognostic Predictors for the efficacy of Immune Checkpoint Inhibitors |
| Date of disclosure of the study information | 2024/02/14 |
| Last modified on | 2024/02/14 15:56:53 |
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Basic information
Public title
Prognostic Predictors for the efficacy of Immune Checkpoint Inhibitors
Acronym
Prognostic Predictors for the efficacy of Immune Checkpoint Inhibitors
Scientific Title
Prognostic Predictors for the efficacy of Immune Checkpoint Inhibitors
Scientific Title:Acronym
Prognostic Predictors for the efficacy of Immune Checkpoint Inhibitors
Region
| Japan |
Condition
Condition
Thoracic cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Thoracic malignancies, led by lung cancer, are the leading cause of cancer-related deaths worldwide and also have a high incidence rate in Japan among both men and women. In this context, various drug discovery efforts are underway, with immune checkpoint inhibitors gaining recent attention. These drugs target the mechanism by which cancer cells evade the body's immune mechanisms. By inhibiting immune escape, these drugs facilitate the re-recognition of cancer antigens by the immune system, thereby exerting antitumor effects. Nivolumab (brand name: Opdivo), pembrolizumab (brand name: Keytruda), and atezolizumab (brand name: Tecentriq) have been newly approved for insurance coverage in Japan. Given this scenario, it is anticipated that future treatments will become increasingly complex, involving combinations with existing cytotoxic anticancer drugs, surgery, and radiation therapy.
This study, conducted by the Department of Respiratory Medicine at Juntendo University Hospital and its affiliated institutions, aims to investigate cases of lung cancer patients treated with checkpoint inhibitors, focusing on exploratory research related to factors associated with efficacy and safety. Specifically, it will utilize indicators such as treatment duration and response duration for efficacy, and incidence of adverse events for safety, to exploratively analyze correlations with various factors (clinical information).
From this research, it is expected that new insights will be gained regarding the optimal combination of treatments for lung cancer patients, as well as prognostic and adverse event-related findings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with lung cancer or malignant pleural mesothelioma at the Department of Respiratory Medicine, Juntendo University Urayasu Hospital between January 1, 2009, and December 31, 2025, or patients diagnosed with lung cancer at another institution and referred to our hospital for anticancer treatment (including immune checkpoint inhibitors) and radiation therapy will be selected.
Key exclusion criteria
Patients deemed inappropriate for the study by the principal investigator or co-investigators.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Sasaki |
Organization
Juntendo University Urayasu Hospital
Division name
Division of respiratory medicine
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu-shi, Chiba
TEL
0473533111
sisasaki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Namba |
Organization
Juntendo University Urayasu Hospital
Division name
Division of respiratory medicine
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu-shi, Chiba
TEL
0473533111
Homepage URL
yknanba@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Urayasu Hospital
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
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421
Tel
0338133111
rinri-urayasu@juntendo-urayasu.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
| 2024 | Year | 02 | Month | 14 | 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
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multi-center retrospective observational study
Management information
Registered date
| 2024 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061182
