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 |
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
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
Japan |
non-small cell lung cancer harboring EGFR mutations
Pneumology |
Malignancy
YES
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
Safety
Comparison of Odds ratios of occurring ILDs between patients with or without MUC4 genetic polymorphisms
To detect risk factors of ILD by multivariate analyses, which are decided before calculating data
Observational
Not applicable |
Not applicable |
Male and Female
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
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
1000
1st name | Koichi |
Middle name | |
Last name | Hagiwara |
Jichi Medical University
Clinical Laboratories for Cardiovascular Diseases
330-8503
1-847 Amanuma Omiya, Saitama City
048-647-2111
hagiwark@saitama-med.ac.jp
1st name | Kunihiko |
Middle name | |
Last name | Kobayashi |
Saitama Medical University International Medical Center
Department of Respiratory Medicine
350-1298
1397-1 Yamane Hidaka, Saitama 350-1298 Japan
042-984-4667
kobakuni@saitama-med.ac.jp
North East Japan Study Group (NEJSG)
North East Japan Study Group (NEJSG)
Non profit foundation
Saitama Medcal University International Medical Cente IRB
1397-1 Yamane Hidaka, Saitama 350-1298 Japan
042-984-4523
chikens@saitama-med.ac.jp
NO
2014 | Year | 11 | Month | 05 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 08 | Day |
2014 | Year | 10 | Month | 08 | Day |
2014 | Year | 11 | Month | 07 | Day |
2017 | Year | 12 | Month | 31 | Day |
2019 | Year | 12 | Month | 31 | Day |
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.
2014 | Year | 11 | Month | 05 | Day |
2022 | Year | 03 | Month | 03 | Day |
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 |