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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015569
Receipt No. R000018052
Scientific Title A prospective observational study of temporal change in pulmonary function during epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) treatment in patients with non-small cell lung carcinoma.
Date of disclosure of the study information 2014/11/01
Last modified on 2014/10/30

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Basic information
Public title A prospective observational study of temporal change in pulmonary function during epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) treatment in patients with non-small cell lung carcinoma.
Acronym A prospective observational study of temporal change in pulmonary function during EGFR-TKI treatment
Scientific Title A prospective observational study of temporal change in pulmonary function during epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) treatment in patients with non-small cell lung carcinoma.
Scientific Title:Acronym A prospective observational study of temporal change in pulmonary function during EGFR-TKI treatment
Region
Japan

Condition
Condition non-small cell lung carcinoma
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study investigates the influence of EGFR-TKI on pulmonary function and diffusion capacity for carbon monoxide (DLCO).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The rate of change in DLCO from baseline after EGFR-TKI administration
Key secondary outcomes (1) Other spirometric parameters change (FEV1, FVC, and VC) from baseline
(2) Change on thin-slice CT findings after EGFR-TKI treatment
(3) Frequency and extent of adverse effect of EGFR-TKI
(4) Response rate of EGFR-TKI

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) Patients with non-small cell lung cancer who are going to receive EGFR-TKI treatment
2) Chemotherapy-naive patients or patients who have not received any chemotherapies more than 1 month
3) Patients of 20 years of age or older
4) Patients with life expectancy >= 3 months
5) Patients who offer the documented agreement to the study
Key exclusion criteria 1) History of thoracic radiotherapy
Target sample size 44

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuyoshi Imaizumi
Organization Fujita Health University School of Medicine
Division name Division of Respiratory Medicine and Clinical Allergy
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL 0562-93-9241
Email jeanluc@fujita-hu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Teppei Yamaguchi
Organization Fujita Health University School of Medicine
Division name Division of Respiratory Medicine and Clinical Allergy
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL 0562-93-9241
Homepage URL
Email yteppei@fujita-hu.ac.jp

Sponsor
Institute Division of Respiratory Medicine and Clinical Allergy,Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Division of Respiratory Medicine and Clinical Allergy,Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2014 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study investigates the influence of EGFR-TKI on pulmonary function including diffusion capacity for carbon monoxide to detect pulmonary toxicity of the drug.

Management information
Registered date
2014 Year 10 Month 30 Day
Last modified on
2014 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018052

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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