UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024664 |
|---|---|
| Receipt number | R000028369 |
| Scientific Title | Japanese lung cancer registry study: Prospective registry database of patients with malignant mesothelioma |
| Date of disclosure of the study information | 2017/04/03 |
| Last modified on | 2021/06/15 07:58:49 |
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Basic information
Public title
Japanese lung cancer registry study: Prospective registry database of patients with malignant mesothelioma
Acronym
Japanese lung cancer registry study: Prospective registry on malignant mesothelioma treatment
Scientific Title
Japanese lung cancer registry study: Prospective registry database of patients with malignant mesothelioma
Scientific Title:Acronym
Japanese lung cancer registry study: Prospective registry on malignant mesothelioma treatment
Region
| Japan |
Condition
Condition
Malignant mesothelioma
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the clinicopathological features of new cases with malignant mesothelioma diagnosed from 1st April 2017 to 31th March 2019 in Japan.
Basic objectives2
Others
Basic objectives -Others
Participation in the prospective database project in International Mesothelioma Interest Group (IMIG)
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
A nationwide prospective registry study on the prognosis and clinicopathological profiles of malignant mesothelioma diagnosed from 1st April 2017 to 31th March 2019 in Japan.
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
All new cases of malignant mesothelioma diagnosed from 1st April 2017 to 31th March 2019 in Japan.
Key exclusion criteria
Patients who refused to participate in this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yoshino |
Organization
Chiba University Graduate School of Medicine
Division name
General Thoracic Surgery
Zip code
5650871
Address
1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba, Japan
TEL
043-222-7171
1royoshino@gmail.com
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Shintani |
Organization
Osaka University Graduate School of Medicine
Division name
General Thoracic Surgery
Zip code
565-0871
Address
2-2-L5, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3152
Homepage URL
https://haigan-touroku.jp/
haigan@thoracic.med.osaka-u.ac.jp
Sponsor or person
Institute
Japanese Joint Committee of Lung Cancer Registry
Institute
Department
Personal name
Funding Source
Organization
Japanese Joint Committee of Lung Cancer Registry
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
Institutional Review Board of Osaka University Hospital
Address
4F, Center of Medical Innovation and Translational Research, 2-2, Inovation Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8290
rinri@hp-crc.med.osaka-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
全国の大学医学部附属病院および地域の基幹施設で参加を希望する施設
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
https://haigan-touroku.jp/
Publication of results
Unpublished
Result
URL related to results and publications
https://haigan-touroku.jp/
Number of participants that the trial has enrolled
351
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
| 2016 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
We monitor all new cases of malignant mesothelioma diagnosed from 1st April 2017 to 31th March 2019 in Japan. Using clinical data from the registry, treatment outcome will be analyzed.
Management information
Registered date
| 2016 | Year | 10 | Month | 31 | Day |
Last modified on
| 2021 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028369
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
