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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024303
Receipt No. R000027991
Scientific Title The prospective observational study of lung wedge resection for cT1a,1bN0M0 Non-Small Lung Cancer patients.
Date of disclosure of the study information 2016/10/05
Last modified on 2017/05/22

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Basic information
Public title The prospective observational study of lung wedge resection for cT1a,1bN0M0 Non-Small Lung Cancer patients.
Acronym The prospective observational study of lung wedge resection for Non-Small Lung Cancer patients.
Scientific Title The prospective observational study of lung wedge resection for cT1a,1bN0M0 Non-Small Lung Cancer patients.
Scientific Title:Acronym The prospective observational study of lung wedge resection for Non-Small Lung Cancer patients.
Region
Japan

Condition
Condition Non-Small Cell Lung Cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine the risk factor of local recurrence after wedge resection for cT1a,1bN0M0 NSCLC patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3-year loco regional recurrence rate
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) patients diagnosed as non-small cell lung cancer or suspected as having non-small cell lung cancer.
2) cT1a or T1b N0M0 patients.
3) PS 0, 1 or2.
Key exclusion criteria 1) patients underwent preoperative radiotherapy and/or chemotherapy.
2) patients with multiple cancers.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyoshi Sawabata
Organization Hoshigaoka Medical center
Division name Depaerment of General Thoraci Surgery
Zip code
Address 4-8-1 Hosigaoka, Hirakata-shi, Osaka 573-8511, Japan
TEL 072-840-2641
Email nsawabata@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Matsutani
Organization Teikyo University School of Medicine
Division name Department of Surgery
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL 03-3964-1231
Homepage URL
Email matsutan@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University School of Medicine
Institute
Department

Funding Source
Organization Teikyo University School of Medicine
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
2016 Year 10 Month 05 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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2016 Year 10 Month 05 Day
Last modified on
2017 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027991

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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