UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024303
Receipt number 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 14:34:58

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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 or person

Institute

Teikyo University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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