UMIN-CTR Clinical Trial

Basic information
Public title	Biomarker for malignant pleural mesothelioma
Acronym	Biomarker for malignant pleural mesothelioma
Scientific Title	Biomarker for malignant pleural mesothelioma
Scientific Title:Acronym	Biomarker for malignant pleural mesothelioma
Region	Japan North America

Condition
Condition	Malignat pleural mesothelioma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to know about prognostic biomarker in mesothelioma
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall 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	18 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with malignant pleural mesothelioma over 18 years old
Key exclusion criteria	patients under 17 years old
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Etsuko Middle name Last name Tagaya
Organization	Tokyo Womens Medical University, Tokyo, Japan
Division name	Department of Respiratory Medicine
Zip code	1628666
Address	8-1 Kawada-cho Shinjuku-ku, Tokyo 162-8666, Japan
TEL	0333538111
Email	tagaya.etsuko@twmu.ac.jp

Public contact
Name of contact person	1st name Ken Middle name Last name Arimura
Organization	Tokyo Womens Medical University, Tokyo, Japan
Division name	Department of Respiratory Medicine
Zip code	1628666
Address	8-1 Kawada-cho Shinjuku-ku, Tokyo 162-8666, Japan
TEL	0333538111
Homepage URL
Email	arimuraken@gmail.com

Sponsor
Institute	Tokyo Womens Medical University, Tokyo, Japan
Institute
Department

Funding Source
Organization	Tokyo Womens Medical University, Tokyo, Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical and Academic Research Promotion center
Address	8-1 Kawada-cho Shinjuku-ku, Tokyo 162-8666, Japan
Tel	0333538111
Email	twmu@esct.bvits.com

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	2022 Year 10 Month 20 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	Preinitiation
Date of protocol fixation	2022 Year 08 Month 19 Day
Date of IRB	2022 Year 08 Month 19 Day
Anticipated trial start date	2022 Year 08 Month 19 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Patients can opt out

Management information
Registered date	2022 Year 10 Month 17 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056081