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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036622
Receipt No. R000040104
Scientific Title Multi-Center observational study to evaluate the relationship between the status of lung/oral flora and therapeutic efficacy of afatinib for EGFR mutated non-small cell lung cancers
Date of disclosure of the study information 2019/05/10
Last modified on 2019/04/29

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Basic information
Public title Multi-Center observational study to evaluate the relationship between the status of lung/oral flora and therapeutic efficacy of afatinib for EGFR mutated non-small cell lung cancers
Acronym observational study to evaluate the relationship between the status of lung/oral flora and therapeutic efficacy of afatinib
Scientific Title Multi-Center observational study to evaluate the relationship between the status of lung/oral flora and therapeutic efficacy of afatinib for EGFR mutated non-small cell lung cancers
Scientific Title:Acronym observational study to evaluate the relationship between the status of lung/oral flora and therapeutic efficacy of afatinib
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the relationship between the status of lung/oral flora and therapeutic efficacy of afatinib
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification of body flora correlated with the tumor response
Key secondary outcomes Correlation between the disease control rate and the body flora and PBMC
Correlation between the progression-free survival and the body flora and PBMC
Correlation between the overall survival andthe body flora and PBMC
Safety


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 advanced or relapsed non small cell lung cancer patients

Key exclusion criteria 1 Duplicate cancer of active
2 Autoimmune disease
3 Severe lung disease(ILD IPF)
4 Infections requiring systemic treatment
5 Serious psychiatric disorders
6 Symptomatic brain metastasis
7 Control poor diabetes
8 Control poor disease(heart disease lung disease liver disease kidney disease)
9 Active Hepatitis (type B virus or type C virus)
10 Systemic steroid administration
11 Pregnant women lactating women or women with a positive pregnancy test
A woman without intention to contraception
A woman wishing to become pregnant or breastfeeding
12 Drug hypersensitivity
13 Cases the attending physician determines that inappropriate to participate in the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tasaka
Middle name
Last name Sadatomo
Organization Hirosaki Universitiy Graduate school of medicine
Division name respiratory medicine
Zip code 0368562
Address 5, Zaifu, Hirosaki
TEL 0172395468
Email tasaka@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name HISASHI
Middle name
Last name TANAKA
Organization Hirosaki Universitiy Graduate school of medicine
Division name respiratory medicine
Zip code 0368562
Address 5, Zaifu, Hirosaki
TEL 0172395468
Homepage URL
Email xyghx335@gmail.com

Sponsor
Institute Hirosaki Universitiy Graduate school of medicine
Institute
Department

Funding Source
Organization Hirosaki Universitiy
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Hirosaki University
Address 5, Zaifu, Hirosaki
Tel 0172395468
Email rinri@hirosaki-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 2018-142
Org. issuing International ID_1 IRB of Hirosaki University
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 05 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
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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 10 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 Prospective observational study

Management information
Registered date
2019 Year 04 Month 29 Day
Last modified on
2019 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040104

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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