UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031067 |
|---|---|
| Receipt number | R000035481 |
| Scientific Title | Prospective registry database of patients with thymic epithelial tumor: Directions for a future Japanese registry-based lung cancer study |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/01/31 13:25:47 |
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Basic information
Public title
Prospective registry database of patients with thymic epithelial tumor: Directions for a future Japanese registry-based lung cancer study
Acronym
Prospective registry database of patients with thymic epithelial tumors
Scientific Title
Prospective registry database of patients with thymic epithelial tumor: Directions for a future Japanese registry-based lung cancer study
Scientific Title:Acronym
Prospective registry database of patients with thymic epithelial tumors
Region
| Japan |
Condition
Condition
Thymic epithelial tumor
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the data in this registry to determine the most recent outcomes and trends related to treatment of thymic epithelial tumor in Japan
Basic objectives2
Others
Basic objectives -Others
Participation in the prospective database project in International Thymic Malignancy Interest Group
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The most recent outcomes (overall and disease-specific survival) and trends related to treatment of thymic epithelial tumor in Japan
Key secondary outcomes
The patient background, surgical results, stage-specific prognosis, and correlations with the primary endpoints
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
New cases of thymic epithelial timors diagnosed from 1st April 2018 to 31th March 2023 in Japan.
Key exclusion criteria
Patients who refused to participate in this study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | HIroshi |
| Middle name | |
| Last name | Date |
Organization
Kyoto University
Division name
Thoracic Surgery
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
TEL
075-753-4300
hdate@kuhp.kyoto-u.ac.jp
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
JLCS, JACS, JRS, JSRE, JATS, JART and JAMIG
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
Medical Center for Translational Research Osaka University Hospital
Address
2-2, Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8296
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
| 2018 | Year | 02 | Month | 01 | 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
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
| 2018 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2033 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2034 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2035 | Year | 03 | Month | 31 | Day |
Other
Other related information
We monitor all new cases of thymic epithelial
tumors diagnosed from 1st April 2018 to 31th March 2023 in Japan. Using clinical data from the registry, treatment outcome will be analyzed.
Management information
Registered date
| 2018 | Year | 01 | Month | 30 | Day |
Last modified on
| 2021 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035481
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
