UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048933 |
|---|---|
| Receipt number | R000055670 |
| Scientific Title | Survey on Lung Cancer Patients' Experience and Awareness of Precision Medicine |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2024/09/17 16:33:07 |
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Basic information
Public title
Survey on Lung Cancer Patient' Experience and Awareness of Precision Medicine
Acronym
Survey on Lung Cancer Patients' Experience and Awareness of Precision Medicine
Scientific Title
Survey on Lung Cancer Patients' Experience and Awareness of Precision Medicine
Scientific Title:Acronym
Survey on Lung Cancer Patients' Experience and Awareness of Precision Medicine
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify factors necessary to achieve optimal personalized medicine and identify differences in opportunities for patients to receive personalized medicine.
Basic objectives2
Others
Basic objectives -Others
Web Survey
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Responses to questions on opportunities to receive personalized medicine.
Key secondary outcomes
Responses to questions on understanding and recognition among lung cancer patients regarding lung cancer treatment and lung cancer-related genetic testing.
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 18 years or older with NSCLC
2.Current or previous drug therapy (not indicate for curative surgery or radiation therapy)
3.Agree to complete the questionnaires
Key exclusion criteria
1.Unable to complete questionnaires
2.Provide inadequate response (Outliers of quantity data, inconsistent responses, unmotivated responses, etc.)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Soeda |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Medical Affairs, Japan Oncology Business Unit
Zip code
1038668
Address
2-1 -1 Nihonbashi Honcho, Chuo-ku, Tokyo JAPAN
TEL
03-3278-2111
japan.oncology.iir.office@takeda.com
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Tsubouchi |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Medical Affairs, Japan Oncology Business Unit
Zip code
1038668
Address
2-1 -1 Nihonbashi Honcho, Chuo-ku, Tokyo JAPAN
TEL
03-3278-2111
Homepage URL
japan.oncology.iir.office@takeda.com
Sponsor or person
Institute
Medical Affairs, Japan Oncology Business Uni, Takeda Pharmaceutical Company Limited.
Institute
Department
Personal name
Funding Source
Organization
Medical Affairs, Japan Oncology Business Uni, Takeda Pharmaceutical Company Limited.
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
Ethics Review Board, Kitamachi Clinic
Address
1-3, KichijojiKitamachi, Musashino, Tokyo JAPAN
Tel
0367798166
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2022 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/haigan/64/4/64_290/_article/-char/ja
Number of participants that the trial has enrolled
200
Results
The actual status of genetic testing from the viewpoint of patients with NSCLC was clarified in this study. These results will aid in the development of a system in which all patients receive optimal personalized medicine.
Results date posted
| 2024 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N.A.
Participant flow
N.A.
Adverse events
N.A.
Outcome measures
N.A.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Web Survey
Management information
Registered date
| 2022 | Year | 09 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055670
