UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prospective observational study of lung wedge resection for cT1a,1bN0M0 Non-Small Lung Cancer patients.
Title of the study (Brief title)	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	Noriyoshi Sawabata
Organization	Hoshigaoka Medical center
Division name	Depaerment of General Thoraci Surgery
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	Noriyuki Matsutani
Organization	Teikyo University School of Medicine
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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