UMIN-CTR Clinical Trial

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 Koichi Middle name Last name Hagiwara
Organization	Jichi Medical University
Division name	Clinical Laboratories for Cardiovascular Diseases
Zip code	330-8503
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 Kunihiko Middle name Last name Kobayashi
Organization	Saitama Medical University International Medical Center
Division name	Department of Respiratory Medicine
Zip code	350-1298
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	Saitama Medcal University International Medical Cente IRB
Address	1397-1 Yamane Hidaka, Saitama 350-1298 Japan
Tel	042-984-4523
Email	chikens@saitama-med.ac.jp

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	Completed
Date of protocol fixation	2014 Year 10 Month 08 Day
Date of IRB	2014 Year 10 Month 08 Day
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	2022 Year 03 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018140