UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050108 |
|---|---|
| Receipt number | R000057085 |
| Scientific Title | An observational study to examine perioperative physical activity, nutrition and quality of life in patients with surgically resected lung cancer |
| Date of disclosure of the study information | 2023/01/23 |
| Last modified on | 2023/03/29 22:01:26 |
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Basic information
Public title
An observational study to examine perioperative physical activity, nutrition and quality of life in patients with surgically resected lung cancer
Acronym
An observational study to examine perioperative physical activity, nutrition and quality of life in patients with surgically resected lung cancer
Scientific Title
An observational study to examine perioperative physical activity, nutrition and quality of life in patients with surgically resected lung cancer
Scientific Title:Acronym
An observational study to examine perioperative physical activity, nutrition and quality of life in patients with surgically resected lung cancer
Region
| Japan |
Condition
Condition
Resectable lung cancer (histologically proven cases and clinically suspected cases before surgery)
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the association between preoperative physical activity, nutrition and postoperative recovery in patients with lung cancer.
Basic objectives2
Others
Basic objectives -Others
Another aim of this study is to examine the association between preoperative physical activity, nutrition and intensity of post-recurrence therapy for lung cancer.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative physical activity , nutrition, and quality of life
Occurrence rates of postoperative complications
Postoperative survivals
Key secondary outcomes
Intensity of post-recurrence therapy
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
1.Histologically proven lung cancer (including preoperatively suspected cases)
2.Written informed consent
3.ECOG performance status:0-2
Key exclusion criteria
1.Biopsy cases
2.Pregnant and lactating patients
3.Patients considered as inappropriate by physicians
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Aoyama |
Organization
Kyoto Katsura Hospital
Division name
Thoracic Surgery
Zip code
615-8256
Address
17 Yamada Hirao, Nishikyo, Kyoto
TEL
075-391-5811
ao.akihiro@gmail.com
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Aoyama |
Organization
Kyoto Katsura Hospital
Division name
Department of Thoracic Surgery
Zip code
615-8256
Address
17 Yamada Hirao, Nishikyo, Kyoto
TEL
075-391-5811
Homepage URL
ao.akihiro@gmail.com
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Kyoto Katsura Hospital Clinical Research Institutional Board
Address
17 Yamada Hirao, Nishikyo, Kyoto
Tel
075-391-5811
noriko.fujita@katsura.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
京都桂病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will examine preoperative physical activity, nutritional status and quality of life (QOL) of the enrolled patients, which will be followed by QOL evaluation after discharge. Patients will be placed in either the sarcopenia group or non-sarcopenia group. Postoperative QOL follow-up will be 3,6,12 months postoperatively. We will continue the routine follow-up for patients with resected lung cancer thereafter.
Management information
Registered date
| 2023 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057085
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
