UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033839 |
|---|---|
| Receipt number | R000038337 |
| Scientific Title | Lung cancer case registry study |
| Date of disclosure of the study information | 2018/08/21 |
| Last modified on | 2020/02/21 18:25:03 |
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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
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
konai@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038337
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
