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 2023/10/12 15:16:28

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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

Email

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


Email

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

Email

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


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

200

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

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

2023 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055670


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name