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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015612
Receipt No. R000018140
Scientific Title Relationship between ILD induced by EGFR-TKI and MUC4 genetic polymorphism in patients harboring EGFR mutations - NEJ022 Study, a case-control study within a cohort
Date of disclosure of the study information 2014/11/05
Last modified on 2018/11/08

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Basic information
Public title Relationship between ILD induced by EGFR-TKI and MUC4 genetic polymorphism in patients harboring EGFR mutations - NEJ022 Study, a case-control study within a cohort
Acronym NEJ022A
Scientific Title Relationship between ILD induced by EGFR-TKI and MUC4 genetic polymorphism in patients harboring EGFR mutations - NEJ022 Study, a case-control study within a cohort
Scientific Title:Acronym NEJ022A
Region
Japan

Condition
Condition non-small cell lung cancer harboring EGFR mutations
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate a correlation between interstitial lung disease (ILD) induced by EGFR-TKI and MUC4 genetic polymorphisms using a case-control study in a cohort
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of Odds ratios of occurring ILDs between patients with or without MUC4 genetic polymorphisms
Key secondary outcomes To detect risk factors of ILD by multivariate analyses, which are decided before calculating data

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pathologically diagnosed non-small cell lung carcinoma
2) Stage IIIB, IV, relapse post operation and no indication for operation and curative irradiation
3) Harboring sensitive EGFR mutations
4) Scheduled monotherapy by EGFR-TKI
5) More than 20 years old
6) Written informed consent
Key exclusion criteria 1) Having drug allergy for EGFR-TKI
2) Pregnant woman, having possibility of pregnancy, or lactating woman
3) Having the other causes of contraindication for EGFR-TKI
4) In addition, the primary doctor judging inappropriate for entry
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Hagiwara
Organization Jichi Medical University
Division name Clinical Laboratories for Cardiovascular Diseases
Zip code
Address 1-847 Amanuma Omiya, Saitama City
TEL 048-647-2111
Email hagiwark@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiko Kobayashi
Organization Saitama Medical University International Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 1397-1 Yamane Hidaka, Saitama 350-1298 Japan
TEL 042-984-4667
Homepage URL
Email kobakuni@saitama-med.ac.jp

Sponsor
Institute North East Japan Study Group (NEJSG)
Institute
Department

Funding Source
Organization North East Japan Study Group (NEJSG)
Organization
Division
Category of Funding Organization Non profit foundation
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 05 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 No longer recruiting
Date of protocol fixation
2014 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 07 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Study procedure
1) Registration: A total of 1000 non-small cell lung cancer patients harboring EGFR mutations scheduled to be treated with EGFR-TKI monotherapy
2) Treatment with EGFR-TKI is done, and ILD is supposed to be observed in approximately 4% of the patients.
3) From ILD patients judged by the primary doctor, typical ILD patients are selected by a radiologist.
4) For a typical ILD case, 8 controls without ILD are picked up from the cohort.
5) MUC4 genetic polymorphisms are estimated among a total of 90 patients consisted of 10 ILD cases and 80 controls.
6) Comparison of Odds ratios of occurring ILD between patients with or without MUC4 genetic polymorphisms is investigated. When getting 45 patients (5 ILDs and 40 controls), an interim analysis is performed.


Management information
Registered date
2014 Year 11 Month 05 Day
Last modified on
2018 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018140

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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