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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031991
Receipt No. R000036492
Scientific Title Evaluation on the usefulness of protocol for pharmacists facilitating laboratory monitoring to ensure safety in lung cancer patients receiving immune checkpoint inhibitors
Date of disclosure of the study information 2018/03/29
Last modified on 2018/03/29

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Basic information
Public title Evaluation on the usefulness of protocol for pharmacists facilitating laboratory monitoring to ensure safety in lung cancer patients receiving immune checkpoint inhibitors
Acronym Usefulness of pharmacists facilitating laboratory monitoring in patients receiving immune checkpoint inhibitors
Scientific Title Evaluation on the usefulness of protocol for pharmacists facilitating laboratory monitoring to ensure safety in lung cancer patients receiving immune checkpoint inhibitors
Scientific Title:Acronym Usefulness of pharmacists facilitating laboratory monitoring in patients receiving immune checkpoint inhibitors
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 effect of a pharmacist-facilitated laboratory monitoring program on the percentage of underwent adequate ADE monitoring in cancer patients receiving immune checkpoint inhibitors
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Adherence to laboratory monitoring which was stated in the protocol
Key secondary outcomes -Immune-related adverse events in early phase
-Number of laboratory order entries by pharmacist
-Required time for laboratory order entries by pharmacist
-Problems associated with the protocol for pharmacists facilitating laboratory monitoring

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 Adult lung cancer patients receiving immune checkpoint inhibitors between 2018 April and 2019 March
Key exclusion criteria 1. Patients previously received immune checkpoint inhibitors.
2. Patients who expected to be difficult to assess irAEs due to dementia or psychiatric diseases.
3. Patients who have severe comorbidities.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Hashida
Organization Kobe City Medical Center General Hospital
Division name Department of Pharmacy
Zip code
Address 2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe, JAPAN
TEL 078-302-4321
Email tohru@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Ikesue
Organization Kobe City Medical Center General Hospital
Division name Department of Pharmacy
Zip code
Address 2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe, JAPAN
TEL 078-302-4321
Homepage URL
Email ikesue@kcho.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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 神戸市立医療センター中央市民病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 29 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
2018 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036492

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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