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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031978
Receipt No. R000036507
Scientific Title TECENTRIQ Drug Use Surveillance(advanced or recurrent non-small cell lung cancer)
Date of disclosure of the study information 2018/04/17
Last modified on 2019/04/04

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Basic information
Public title TECENTRIQ Drug Use Surveillance(advanced or recurrent non-small cell lung cancer)
Acronym TECENTRIQ Drug Use Surveillance(NSCLC)
Scientific Title TECENTRIQ Drug Use Surveillance(advanced or recurrent non-small cell lung cancer)
Scientific Title:Acronym TECENTRIQ Drug Use Surveillance(NSCLC)
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This surveillance study is conducted to confirm incidence of adverse drug reactions(ADRs) in Japanese clinical setting.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of ADRs.
Key secondary outcomes - The time of onset of ADRs.
- The treatment status and outcome of ADRs.
- The incidence of ADRs for each patient baseline characteristic.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patients who are scheduled to receive TECENTRIQ at contracted institutions during this surveillance's enrollment period.
Key exclusion criteria No criteria
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Kawashima
Organization Chugai Pharmaceutical Co. Ltd.
Division name Real world data science Dept.
Zip code 103-8324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0769
Email nemotomst@chugai-pharm.co.jp

Public contact
Name of contact person
1st name Ayaka
Middle name
Last name Shimizu
Organization Chugai Pharmaceutical Co. Ltd.
Division name Real world data science Dept.
Zip code 103-8324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0905
Homepage URL
Email shimizuayk@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co. Ltd.
Institute
Department

Funding Source
Organization Chugai Pharmaceutical 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 None
Address None
Tel None
Email None

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 04 Month 17 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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 26 Day
Date of IRB
2018 Year 01 Month 26 Day
Anticipated trial start date
2018 Year 04 Month 18 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Adverse events, Patient baseline characteristics, Treatment history

Management information
Registered date
2018 Year 03 Month 29 Day
Last modified on
2019 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036507

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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