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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033839
Receipt No. R000038337
Scientific Title Lung cancer case registry study
Date of disclosure of the study information 2018/08/21
Last modified on 2020/02/21

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Basic information
Public title Lung cancer case registry study
Acronym Lung cancer case registry study
Scientific Title Lung cancer case registry study
Scientific Title:Acronym Lung cancer case registry study
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Medicine in general Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 By accumulating clinical information and samples of patients in lung cancer and examining evaluation items on a sustainable and long-term basis, we will contribute to the development and establishment of new treatments for lung cancer disease in the future.
Basic objectives2 Others
Basic objectives -Others Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival time, progression-free survival term are main evaluation items, and exploratory evaluation is performed for all items collected.
Key secondary outcomes

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 1) Patients diagnosed with lung cancer
2) Patients who agreed to participate in the research in writing
Key exclusion criteria 1) Patients judged inappropriate for this study as judged by researchers
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Toyohiro
Middle name
Last name Hirai
Organization Kyoto University
Division name Department of Respiratory Medicine
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL 075-751-3830
Email konai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Ozasa
Organization Kyoto University
Division name Department of Respiratory Medicine
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL 075-751-3830
Homepage URL http://kukonai.com
Email konai@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization university research funds
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Certified Review Board
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

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 京都大学医学部付属病院(京都府)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 21 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
2018 Year 08 Month 21 Day
Date of IRB
2019 Year 12 Month 02 Day
Anticipated trial start date
2018 Year 08 Month 21 Day
Last follow-up date
2023 Year 08 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, we accumulate clinical information and samples of patients in lung cancer, examine evaluation items on a sustainable and long-term basis, and contribute to the development and establishment of new treatments for lung cancer in the future.
For lung cancer not established for curative treatment for many patients, collect data on lung cancer patients and consolidate information on patients and treatments to promote the elucidation of etiology and pathology, development of diagnosis, treatment and prevention methods. By doing so, it becomes possible to promote clarification of the pathology of lung cancer and treatment and research in the future. In this study, we will establish a case accumulation system for patients with lung cancer and follow up on patient background, living environment, living conditions, symptoms of lung cancer and treatment history. By collecting not only clinical information but also patient specimens, we can collaborate with experts such as genome analysis, omics analysis and other ministries and agencies, institutions etc based on collected clinical information and specimens, It is expected that clarification of the pathology of lung cancer and development of new therapy method will be promoted dramatically.

Management information
Registered date
2018 Year 08 Month 21 Day
Last modified on
2020 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038337

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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