UMIN-CTR Clinical Trial

Basic information
Public title	Determination of minimally important difference (MID) of EQ5D VAS and respiratory function in patients underwent lung resection for lung cancer
Acronym	Determination of MID of QOL and respiratory function in lung cancer surgery
Scientific Title	Determination of minimally important difference (MID) of EQ5D VAS and respiratory function in patients underwent lung resection for lung cancer
Scientific Title:Acronym	Determination of MID of QOL and respiratory function in lung cancer surgery
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine MID of EQ5D VAS and respiratory function in patients underwent lung resection for lung cancer.
Basic objectives2	Others
Basic objectives -Others	To determine MID of EORTC QLQ C30 GHS and 6-minute walk test.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	MID of EQ5D VAS and respiratory function one year after lung resection.
Key secondary outcomes	MID of EORTC QLQ C30 GHS and 6MWT

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 who will undergo lung resection for lung cancer or who will undergo diagnostic surgery on suspicion of early lung cancer
Key exclusion criteria	1)reading disability of Japanese, 2)severe visual disorder, 3)cognitive impairment or impairment of decision-making ability, 4)pathological diagnosis except for lung cancer, 5)in the following cases, this protocol will be terminated, i)postoperative relapse, ii)metachronous lung cancer, iii)multiple primary cancer of other organ requiring major surgery, iv)disease or injury deteriorating QOL significantly
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Hideo Middle name Last name Ichimura
Organization	Hitachi Medical Education and Research Center, University of Tsukuba
Division name	Department of Thoracic Surgery
Zip code	317-0077
Address	2-1-1 Jyounan, Hitachi, Ibaraki, Japan
TEL	+81-294-23-1111
Email	ichimura@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Hideo Middle name Last name Ichimura
Organization	Hitachi Medical Education and Research Center, University of Tsukuba
Division name	Department of Thoracic Surgery
Zip code	317-0077
Address	2-1-1 Jyounan, Hitachi, Ibaraki, Japan
TEL	+81-294-23-1111
Homepage URL
Email	ichimura@md.tsukuba.ac.jp

Sponsor
Institute	Department of Thoracic Surgery, Hitachi Medical Education and Research Center, University of Tsukuba
Institute
Department

Funding Source
Organization	None
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	The ethics review board of the hospital administration headquarters, Hitachi Ltd.
Address	2-1-1 Jyounan, Hitachi, Ibaraki, Japan
Tel	+81-294-23-1111
Email	webkanrisha.nichibyo.gd@hitachi.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	2019 Year 10 Month 07 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	Enrolling by invitation
Date of protocol fixation	2019 Year 08 Month 30 Day
Date of IRB	2019 Year 10 Month 07 Day
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2026 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In this prospective single-institutional study, QOL survey using EQ5D-5L and EORTC-QLQ-C30/LC13 is scheduled preoperatively, on postoperative 1-month, 1, 3, 5-year. MID was determined using a multiple categorical response scale 1 year after surgery.

Management information
Registered date	2019 Year 08 Month 30 Day
Last modified on	2019 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043172