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

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 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


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

Value
https://center6.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