UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030481
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email lung@tosei.or.jp

Sponsor
Institute Department of Respiratory Medicine and Allergy, Tosei General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034804

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.