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
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
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
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
