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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021904
Receipt No. R000025251
Scientific Title Prospective observational results of pulmonary resection for over 75 years-old patients with non-small cell lung cancer - Multi-institutional study in Japan -
Date of disclosure of the study information 2016/04/17
Last modified on 2018/04/10

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Basic information
Public title Prospective observational results of pulmonary resection for over 75 years-old patients with non-small cell lung cancer - Multi-institutional study in Japan -
Acronym Prospective observational study of pulmonary resection for elderly patients with lung cancer
Scientific Title Prospective observational results of pulmonary resection for over 75 years-old patients with non-small cell lung cancer - Multi-institutional study in Japan -
Scientific Title:Acronym Prospective observational study of pulmonary resection for elderly patients with lung cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In an aging society, the lung cancer population is also aging. Since the comorbidities increase with age, both postoperative mortality and morbidity of pulmonary resection for elderly patients with non-small cell lung cancer (NSCLC) have been reported to be higher than those for non-elderly patients. However, results reported until now are retrospective and single institutional. We conducted a multi-institutional and prospectively observational study for > 75 years patients with completely resected NSCLC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Operative morbidity
Key secondary outcomes Operative mortality
Risk factors of operative morbidity
Postoperative change of KPS
Postoperative survival

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
100 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria for patients of the present study were as follows;
1)histologically confirmed as NSCLC
2)completely resected, including ipsilateral pulmonary metastasis (PM) and R0 (un), 3)75 or older than 75 years at the time of surgery.
Key exclusion criteria Patient refusal
Target sample size 275

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tokujiro Yano
Organization National Hospital Organization Beppu Medical Center
Division name General Thoracic Surgery
Zip code
Address 1473 Uchikamado, Beppu
TEL 0977-67-11111
Email tokujiro@hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tokujiro Yano
Organization National Hospital Organization Beppu Medical Center
Division name General Thoracic Surgery
Zip code
Address 1473 Uchikamado, Beppu
TEL 0977-67-11111
Homepage URL
Email tokujiro@hosp.go.jp

Sponsor
Institute Dept. General Thoracic Surgery,
National Hospital Organization Beppu Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 旭川医療センター、帯広病院、北海道がんセンター、西新潟中央病院、水戸医療センター、渋川医療センター、高崎総合医療センター、東京医療センター、東京病院、横浜医療センター、長良医療センター、東広島医療センター、呉医療センター、四国がんセンター、高知病院、九州がんセンター、九州医療センター、嬉野医療センター、長崎医療センター、別府医療センター、大阪医療センター、埼玉病院

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1.Yano T, et al.  A prospective observational study of pulmonary resection for non-small cell lung cancer in patients older than 75 years.  Semin Thorac Cardiovasc Surg 2017, 29:540-547 

2. Yano T, et al. The influence of comorbidity on the postoperative survival in elderly (>75 years old) patients with 
lung cancer. Gen Thorac Cardiovasc Surg, 2018 (in press)
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 Completed
Date of protocol fixation
2014 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
2017 Year 08 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information From March 2014 through April 2015, 314 preoperative patients were tentatively registered. Of those preoperatively registered patients, 264 were postoperatively identified to meet the inclusion criteria for this study. The reason for exclusion was no diagnosis of non-small cell lung cancer in 21 patients, incomplete resection in 19 patients, no performance of surgery in 6 and other reason in one.

Management information
Registered date
2016 Year 04 Month 14 Day
Last modified on
2018 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025251

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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