UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000019441