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

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 - NEJ022A

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015612

Enrollment

1000

Registered

2014-11-05

Start date

2014-11-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer harboring EGFR mutations

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Comparison of Odds ratios of occurring ILDs between patients with or without MUC4 genetic polymorphisms	—

Secondary

Measure	Time frame
To detect risk factors of ILD by multivariate analyses, which are decided before calculating data	—

Countries

Japan

Contacts

Public ContactKunihiko Kobayashi

Saitama Medical University International Medical Center Department of Respiratory Medicine

kobakuni@saitama-med.ac.jp042-984-4667

Outcome results