UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015569 |
|---|---|
| Receipt number | 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 20:22:38 |
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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
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
jeanluc@fujita-hu.ac.jp
Public contact
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
yteppei@fujita-hu.ac.jp
Sponsor or person
Institute
Division of Respiratory Medicine and Clinical Allergy,Fujita Health University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018052
| Research Plan | |
|---|---|
| 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 |
