UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037864
Receipt number R000043172
Scientific Title Determination of minimally important difference (MID) of EQ5D VAS and respiratory function in patients underwent lung resection for lung cancer
Date of disclosure of the study information 2019/10/07
Last modified on 2019/11/17 08:44:21

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043172


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name