UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036622 |
|---|---|
| Receipt number | 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 | 2024/01/16 00:25:14 |
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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
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
xyghx335@gmail.com
Sponsor or person
Institute
Hirosaki Universitiy Graduate school of medicine
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040104
| 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 |
