UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003630 |
|---|---|
| Receipt number | R000004181 |
| Scientific Title | Japan Nutrition and QOL survey in patients with advanced non-small cell Lung Cancer study (TORG0912) |
| Date of disclosure of the study information | 2010/05/18 |
| Last modified on | 2019/02/25 10:03:27 |
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Basic information
Public title
Japan Nutrition and QOL survey in patients with advanced non-small cell Lung Cancer study (TORG0912)
Acronym
Japan Nutrition and QOL survey in patients with advanced non-small cell Lung Cancer study (TORG0912)
Scientific Title
Japan Nutrition and QOL survey in patients with advanced non-small cell Lung Cancer study (TORG0912)
Scientific Title:Acronym
Japan Nutrition and QOL survey in patients with advanced non-small cell Lung Cancer study (TORG0912)
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine this study will be conducted the course of clinical parameter in stage 4 non small cell lung cancer, and to examine the relationship between body weight changes and QOL changes
Basic objectives2
Others
Basic objectives -Others
Prospective observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight
QOL evaluation (MDASI-J and QOL-ACD)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Non-small cell lung cancer (Histologically or cytologically confirmed)
2) Stage IV disease by UICC-TNM
3) Non-small cell lung cancer patients without treatment history
4) ECOG performance status must be 0-2
Key exclusion criteria
1) Patients with planned surgery throughout study participation
2) Patients without capacity to consent
3) Patient who passed over 2month since disease diagnosis
4) Patients without capacity to fill out their QOL survey sheet correctly.
5) Patients without capacity to perform handgrip test (only at the sites which evaluate Handgrip strength)
6) Patients without notification of their cancer disease
7) Concomitant malignancy
8) Patients with potential disease affecting food intake
9) Patients with uncontrolled severe diabetes which may bring rapid body weight decrease.
10) Patients with uncontrolled psychiatric disorder
11) Patients with potential disease affecting QOL survey and handgrip test.
12) Patient who have other conditions judged by investigator not to be suitable for this study participation
Target sample size
440
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Eguchi |
Organization
Teikyo university school of medicine
Division name
Division of Medical oncology
Zip code
Address
2-11-1, KAGA, ITABASHI-KU TOKYO 173-8606 JAPAN
TEL
03-3964-1211
keguchi@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kojima |
Organization
Thoracic Oncology Research Group, TORG
Division name
Head office
Zip code
Address
LA.PRYLE 822, 3-1-2, Shin-Yokohama, Kohoku-ku, 222-0033, JAPAN
TEL
045-479-8948
Homepage URL
https://www.torg.or.jp
torg-kashiro@song.ocn.ne.jp
Sponsor or person
Institute
Thoracic Oncology Research Group,TORG
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/27003901
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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Prospective observation study.
Register the patients who meet registration criteria, and follow their clinical course for 1 year.
Management information
Registered date
| 2010 | Year | 05 | Month | 18 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004181
| Research Plan | |
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| 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 |
