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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033593
Receipt No. R000037985
Official scientific title of the study Investigation of preoperative biopsy in lung cancer surgical cases
Date of disclosure of the study information 2018/08/01
Last modified on 2018/08/01

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Basic information
Official scientific title of the study Investigation of preoperative biopsy in lung cancer surgical cases
Title of the study (Brief title) Investigation of preoperative biopsy in lung cancer surgical cases
Region
Japan

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

Objectives
Narrative objectives1 Study the significance of preoperative biopsy in lung cancer surgical cases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Operation time
Key secondary outcomes Biopsy results
Intraoperative bleeding volume
Overall survival, survival rate
Recurrence rate
Hospitalization period, entry into an unexpected intensive care unit

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 Lung cancer cases in which surgery was performed at our center during the period from January 1, 2006 to the end of June 2016
Key exclusion criteria Patient, or family refuses to participate in the study
Target sample size 310

Research contact person
Name of lead principal investigator Takehiro Izumo
Organization Japanese Red Cross Medical Center
Division name Respiratory Medicine
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-3400-1311
Email drtake1118@gmail.com

Public contact
Name of contact person Takehiro Izumo
Organization Japanese Red Cross Medical Center
Division name Respiratory Medicine
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-3400-1311
Homepage URL
Email drtake1118@gmail.com

Sponsor
Institute Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization Japanese Red Cross Medical Center
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
2018 Year 08 Month 01 Day

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 01 Month 01 Day
Anticipated trial start date
2006 Year 01 Month 01 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 Single facility observational study

Management information
Registered date
2018 Year 08 Month 01 Day
Last modified on
2018 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037985

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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