UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027520 |
|---|---|
| Receipt number | R000031551 |
| Scientific Title | The impact of anticancer therapy on antitumor immunity in patients with thoracic cancers |
| Date of disclosure of the study information | 2017/05/29 |
| Last modified on | 2023/12/03 12:57:59 |
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Basic information
Public title
The impact of anticancer therapy on antitumor immunity in patients with thoracic cancers
Acronym
Anticancer therapy and antitumor immunity
Scientific Title
The impact of anticancer therapy on antitumor immunity in patients with thoracic cancers
Scientific Title:Acronym
Anticancer therapy and antitumor immunity
Region
| Japan |
Condition
Condition
Lung cancer, thymoma, thymic cancer, malignant mesothelioma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of anticancer therapy on antitumor immunity in patients with thoracic cancers.
Basic objectives2
Others
Basic objectives -Others
Primary objective of this study is to establish the biomarkers of immune-checkpoint inhibitors. Further, we evaluate the influence of chemotherapy and radiotherapy on antitumor immunity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The impact of anticancer therapy on antitumor immunity in patients with thoracic cancers.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with thoracic cancers who are treated with 1st line chemotherapy, radical radiotherapy, or immunotherapy.
Key exclusion criteria
N/A
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
9518520
Address
1-757 Asahimachidori, Chuouku, Niigata
TEL
0253689325
satoshi7@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
9508510
Address
1-757 Asahimachidori, Chuouku, Niigata
TEL
025-368-9325
Homepage URL
satoshi7@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Niigata University Graduate School of Medical and Dental Sciences
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
Niigata University Graduate School of Medical and Dental Sciences
Address
1-754 Asahimachi-dori
Tel
025-227-2625
sanonao@adm.niigata-u.ac.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
| 2017 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
Not analyzed.
Number of participants that the trial has enrolled
249
Results
Patient accrual for this study has been completed and is being analyzed.
Results date posted
| 2023 | Year | 12 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient accrual for this study has been completed and is being analyzed.
Participant flow
Patient accrual for this study has been completed and is being analyzed.
Adverse events
Patient accrual for this study has been completed and is being analyzed.
Outcome measures
Patient accrual for this study has been completed and is being analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 28 | 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
The antitumor immunity in patients with thoracic cancers is evaluated before and after anticancer therapy.
Management information
Registered date
| 2017 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031551
| 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 |
