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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013293
Receipt No. R000015498
Scientific Title Evaluation of efficacy of postoperative follow-up after resection for lung cancer
Date of disclosure of the study information 2014/02/27
Last modified on 2016/02/28

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Basic information
Public title Evaluation of efficacy of postoperative follow-up after resection for lung cancer
Acronym postoperative follow-up for lung cancer
Scientific Title Evaluation of efficacy of postoperative follow-up after resection for lung cancer
Scientific Title:Acronym postoperative follow-up for lung cancer
Region
Japan

Condition
Condition Patients who underwent resection for lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of postoperative follow-up path prospectively.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Detection rates of recuurence at the three-years after resection (symptomatice or asymptomatic)
Key secondary outcomes Completion rate of postopertaive follow-up.
Five-year survival rate.
Treatment for the recurrence.
Recurrence site.
Detection rate of metachronous cancer

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.Completely resected comfirmed non-small cell lung cancer.
2.Obtained informed concent
Key exclusion criteria 1.Active other organ cancer.
2.Judged an improper case by a doctor
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shikgei Sawada
Organization Shikoku Cancer Center
Division name Department of Thoracic Surgery
Zip code
Address 160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture
TEL 089-999-1111
Email ssawada@shikoku-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Sawada
Organization Shikoku Cancer Center
Division name Department of Thoracic Surgery
Zip code
Address 160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture
TEL 089-999-1111
Homepage URL http://www.shikoku-cc.go.jp/hospital/
Email ssawada@shikoku-cc.go.jp

Sponsor
Institute Shikoku Cancer Center
Institute
Department

Funding Source
Organization N/A
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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 27 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 No longer recruiting
Date of protocol fixation
2013 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2014 Year 02 Month 27 Day
Last modified on
2016 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015498

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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