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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016756
Receipt No. R000019441
Scientific Title Multi-institutional cohort study of evaluating safety and efficacy of surgical treatment for elderly lung cancer
Date of disclosure of the study information 2015/03/09
Last modified on 2019/03/13

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Basic information
Public title Multi-institutional cohort study of evaluating safety and efficacy of surgical treatment for elderly lung cancer
Acronym cohort study of surgery for elderly lung cancer
Scientific Title Multi-institutional cohort study of evaluating safety and efficacy of surgical treatment for elderly lung cancer
Scientific Title:Acronym cohort study of surgery for elderly lung cancer
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Surgery in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluating correlation between comprehensive assessment of elderly patients, morbidity and prognosis in elderly lung cancer patients who underwent surgical treatment
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safetly
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
75 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Lung cancer patients of 75 years old and more who underwent surgical treatment
Key exclusion criteria Nothing
Target sample size 750

Research contact person
Name of lead principal investigator
1st name Hiroshige
Middle name
Last name Nakamura
Organization Tottori University
Division name General Thoracic Surgery
Zip code 683-8504
Address 36-1 Nishi-cho, Yonago, Tottori 683-8504, Japan
TEL 0859-38-6737
Email hnaka@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name Hisashi
Middle name
Last name Saji
Organization St. Marianna University School of Medicine
Division name Chest Surgery
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL 044-977-8111
Homepage URL
Email saji-q@ya2.so-net.ne.jp

Sponsor
Institute Chest Surgery, St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization Nothing
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 St. Marianna Univ. IRB
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel 0449778111
Email saji-q@ya2.so-net.ne.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

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 09 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/29240884
Publication of results Unpublished

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29240884
Number of participants that the trial has enrolled 1019
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
2014 Year 12 Month 08 Day
Date of IRB
2015 Year 02 Month 17 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information under writing

Management information
Registered date
2015 Year 03 Month 09 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019441

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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