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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018602
Receipt No. R000021528
Scientific Title Isolated tumor cell in lung cancer operation, multi center, prospective, observational study
Date of disclosure of the study information 2015/08/08
Last modified on 2017/02/07

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Basic information
Public title Isolated tumor cell in lung cancer operation, multi center, prospective, observational study
Acronym Isolated tumor cell in lung cancer operation, ILO1501
Scientific Title Isolated tumor cell in lung cancer operation, multi center, prospective, observational study
Scientific Title:Acronym Isolated tumor cell in lung cancer operation, ILO1501
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to know the prognostic factor aroun lung cancer operation using isolated tumor cell.
Basic objectives2 Others
Basic objectives -Others observational study
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes detection of isolated tumor cell using Screen Cell method
Key secondary outcomes relation of isolated tumor cell and pathological factor
relation of isolated tumor cell and operation time

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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Preoperative diagnosis as primary non small cell lung cancer
2.clinical stage, T1b-T2, N0M0
3.lobectomy, bi-lobectomy or pneumonectomy
4.consolidation/GGO ratio > 50%
5.ECOG PS0,1
6. chemotherapy naive
7. having operabirity
Key exclusion criteria 1. other active malingant tumor
2. HBV, HCV, HIV
3. fever up over 38
4. having steroid therapy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyoshi Sawabata
Organization Hoshigaoca Medical Center
Division name thoracic surgery
Zip code
Address 4-8-1 Hoshigaoka, Maikata city, Osaka, Japan
TEL 06-6879-2595
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 Surgery
Zip code
Address 2-11-1 Kaga, Itabashi-ku Tokyo, Japan
TEL 03-3964-1231
Homepage URL
Email matsutan@med.teikyo-u.ac.jp

Sponsor
Institute Hoshigaoca Medical Center
Institute
Department

Funding Source
Organization B 25293301
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 星ヶ丘医療センター(大阪府)
山形県立中央病院(山形県)
九州がんセンター(福岡県)
帝京大学(東京都)
浜松医大(静岡県)
順天堂大学(東京都)
東京医大(東京都)
済生会横浜市南部病院(神奈川県)
大阪大学(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 08 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
2015 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2016 Year 07 Month 31 Day
Date of closure to data entry
2016 Year 07 Month 31 Day
Date trial data considered complete
2016 Year 08 Month 31 Day
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information isolated tumor cell using Screen Cell method
pathological factor
operative factor

Management information
Registered date
2015 Year 08 Month 08 Day
Last modified on
2017 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021528

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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