UMIN-CTR Clinical Trial

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
Email	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/
Email	haigan@thoracic.med.osaka-u.ac.jp

Sponsor
Institute	Japanese Joint Committee of Lung Cancer Registry
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035481