UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035119 |
|---|---|
| Receipt number | R000040028 |
| Scientific Title | Blood heregulin and its relation with efficacy of EGFR-tyrosine kinase inhibitor in EGFR-mutant non-small cell lung cancer |
| Date of disclosure of the study information | 2018/12/10 |
| Last modified on | 2019/06/05 10:22:50 |
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Basic information
Public title
Blood heregulin and its relation with efficacy of EGFR-tyrosine kinase inhibitor in EGFR-mutant non-small cell lung cancer
Acronym
Blood heregulin in EGFR-mutant NSCLC
Scientific Title
Blood heregulin and its relation with efficacy of EGFR-tyrosine kinase inhibitor in EGFR-mutant non-small cell lung cancer
Scientific Title:Acronym
Blood heregulin in EGFR-mutant NSCLC
Region
| Japan |
Condition
Condition
EGFR-mutant NSCLC
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the relation of blood heregulin level with the efficacy of EGFR-tyrosine kinase inhibitor in EGFR-mutant NSCLC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the relation of blood heregulin level with the responsiveness of EGFR-TKI
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.Pathologically diagnosed NSCLC
2.Stage 3B/IV, or recurrence of post surgery
3.EGFR mutant
4.EGFR-TKI-naive
5.Blood sampled prior to EGFR-TKI therapy
6.Age >20 years
7.patients with signed informed consent form except dead patients
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakagawa |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-sayama Osaka
TEL
0723-66-0221
nakagawa@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Kimio |
| Middle name | |
| Last name | Yonesaka |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-sayama Osaka
TEL
0723-66-0221
Homepage URL
yonesaka@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Boehringer-Ingelheim
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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2018 | Year | 12 | Month | 10 | 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
76
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
| 2016 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
a)age
b)sex
c)PS
d)Histology
e)Clinial stage
f)Smoking history
g)EGFR mutation type
h)EGFR-TKI therapy
i)prior therapy
j)survival
Management information
Registered date
| 2018 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040028
| Research Plan | |
|---|---|
| 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 |
