UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030481 |
|---|---|
| Receipt number | R000034804 |
| Scientific Title | A prospective longitudinal observational study of health status in patients with lung cancer (TOSEI-LC) |
| Date of disclosure of the study information | 2017/12/21 |
| Last modified on | 2019/06/27 23:13:55 |
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Basic information
Public title
A prospective longitudinal observational study of health status in patients with lung cancer (TOSEI-LC)
Acronym
TOSEI-LC
Scientific Title
A prospective longitudinal observational study of health status in patients with lung cancer (TOSEI-LC)
Scientific Title:Acronym
TOSEI-LC
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether the health status worsens over time in patients with lung cancer
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
EORTC-QLQ-C30 (Summary score)
Key secondary outcomes
EORTC-QLQ-C30 (all items), SF-36, SGRQ, BFI, HADS, EQ-5D-5L, mMRC, Dyspnea-12, 6-minutes walk distance, pulmonary function test (FVC, DLco, FEV1), Grip strength test, Lower limb muscle strength test. Differences when interstitial pneumonia or chronic obstructive pulmonary disease is complicated
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 or cytologically confirmed lung cancer
2. Clinical stage IIIB, IV or postoperative recurrence
3. No prior chemotherapy (Adjuvant chemotherapy is permitted)
4. Estimated life expectancy of at least 3 months
5. Written informed consent
Key exclusion criteria
1. Patients who are difficult to answer in the questionnaire form
2. Patients who are difficult to perform exercise test
3. Patients who have been judged by the investigator to be inappropriate in this clinical trial for other reasons
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoki Kimura |
Organization
Tosei General Hospital
Division name
Department of Respiratory Medicine and Allergy
Zip code
Address
160 Nishioiwake-cho, Seto, Aichi
TEL
+81561825101
lung@tosei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Suzuki |
Organization
Tosei General Hospital
Division name
Department of Respiratory Medicine and Allergy
Zip code
Address
160 Nishioiwake-cho, Seto, Aichi
TEL
+81561825101
Homepage URL
lung@tosei.or.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Allergy, Tosei General Hospital
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
None
Name of secondary funder(s)
None
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
公立陶生病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 21 | 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
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will evaluate primary and secondary outcomes at the first time, 3 months, and 6 months later.
Management information
Registered date
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2019 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034804
