UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015612
Receipt number 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 2022/03/03 16:33:32

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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 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 or person

Institute

North East Japan Study Group (NEJSG)

Institute

Department

Personal name



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

Value
https://center6.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