UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030939 |
|---|---|
| Receipt number | R000035296 |
| Scientific Title | Multicenter, prospective observational study to identify peripheral blood-derived epigenome markers correlated with blood trough value and adverse events of afatinib in EGFR mutation-positive non-small cell lung cancer patients |
| Date of disclosure of the study information | 2018/01/27 |
| Last modified on | 2024/02/08 08:00:26 |
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Basic information
Public title
Multicenter, prospective observational study to identify peripheral blood-derived epigenome markers correlated with blood trough value and adverse events of afatinib in EGFR mutation-positive non-small cell lung cancer patients
Acronym
Afatinib PEGx study
Scientific Title
Multicenter, prospective observational study to identify peripheral blood-derived epigenome markers correlated with blood trough value and adverse events of afatinib in EGFR mutation-positive non-small cell lung cancer patients
Scientific Title:Acronym
Afatinib PEGx study
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify peripheral blood epigenome marker correlation with blood trough value and adverse events of afatinib in EGFR mutation-positive non-small cell lung cancer patients to contribute future appropriate patient selection
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify peripheral blood epigenome marker correlation with blood trough value and adverse events of afatinib
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Histologically or cytologically confirmed diagnosis of non-squamous cell and non-small cell lung cancer
Stage IIIB or Stage IV advanced unresectable, postoperative recurrent cancer
Using afatinib as first line treatment
Age more than 20 years at screening
ECOG performance status 0-1
The function of organs(marrow, liver, kidney, etc.) is maintained enough
Life expectancy more than 3 months
Writing consent is obtained
Key exclusion criteria
Idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug pneumonia, etc. are complicated
Active other malignancy
HBs antigen positive
HBs or HBc antibody positive and HBV-DNA positive
HIV or HCV carrier
Adjuvant chemotherapy
Infection to need to treat with antibiotics or antifungal agent via intravenous administration
Not obtain the consent of taking the sample
Serious psychiatric disorder
Women who are pregnant, nursing, or who plan to become pregnant and Men who plan to father a child while in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Sawa |
Organization
Gifu City Hospital
Division name
Chemotherapy Center
Zip code
550-8513
Address
7-1 Kashimacho, Gifu city, Gifu
TEL
058-251-1101
sawatoshiyuki@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Oguri |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
085-853-8216
Homepage URL
t-oguri@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Toshiyuki Sawa
Gifu City Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
052-853-8077
clinical_research@med.nagoya-cu.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
名古屋市立大学大学院（愛知県）、岐阜市民病院（岐阜県）、岐阜大学大学院（岐阜県）、愛知県がんセンター中央病院（愛知県）、名古屋市立西部医療センター（愛知県）、名古屋市立東部医療センター（愛知県）、長良医療センター（岐阜県）、岐阜県総合医療センター（岐阜県）、海南病院（愛知県）、名古屋記念病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 27 | 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
11
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
| 2018 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 14 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 14 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Wu YL, Zhou C, Hu CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014; 15:213-22.
Management information
Registered date
| 2018 | Year | 01 | Month | 22 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035296
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
