UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035119
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yonesaka@med.kindai.ac.jp

Sponsor
Institute Kindai University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040028

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.