UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036149 |
|---|---|
| Receipt number | R000041153 |
| Scientific Title | Prospective observational study of EGFR mutation allele frequency using Cell free DNA |
| Date of disclosure of the study information | 2019/03/13 |
| Last modified on | 2021/03/12 10:22:02 |
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Basic information
Public title
Prospective observational study of EGFR mutation allele frequency using Cell free DNA
Acronym
EGFR mutation allele frequency study
Scientific Title
Prospective observational study of EGFR mutation allele frequency using Cell free DNA
Scientific Title:Acronym
EGFR mutation allele frequency study
Region
| Japan |
Condition
Condition
non small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To measure the allele frequency of EGFR mutation using cell free DNA iin patients with L858R mutation positive non-small cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in EGFR mutation allele frequency
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
1. Patients with L858R mutation
2. Patients with unresectable or relapsing non small cell lung cancer
3. Patients over 20 years old at consent acquisition date
4. Patients receiving afatinib
5. Patients who can provide blood samples
6. Patients who agreed to participate in this study in writing
Key exclusion criteria
1. Patients with interstitial pneumonia
2. Patients with serious complications
3. Patients with a history of serious hypersensitivity
4. Patients who are judged inappropriate to participate in this study by the research director or research contributor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second division, Depertment of Internal Medicine
Zip code
431-3129
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3129 Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Akahori |
Organization
Hamamatsu University School of Medicine
Division name
Second division, Depertment of Internal Medicine
Zip code
431-3129
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3129 Japan
TEL
053-435-2263
Homepage URL
dakahori@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan 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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3129 Japan
Tel
053-435-2111
rinri@hama-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
| 2019 | Year | 03 | Month | 13 | 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
33
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 | 11 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-center prospective observational study
Management information
Registered date
| 2019 | Year | 03 | Month | 11 | Day |
Last modified on
| 2021 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041153
