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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007093
Receipt No. R000008351
Scientific Title Retrospective analysis for the safety of maneuver and the comparison between the image evaluation, the pathological findings, and the final diagnosis, among patients for whom CT-guided biopsy is performed.
Date of disclosure of the study information 2012/01/17
Last modified on 2012/01/31

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Basic information
Public title Retrospective analysis for the safety of maneuver and the comparison between the image evaluation, the pathological findings, and the final diagnosis, among patients for whom CT-guided biopsy is performed.
Acronym Retrospective analysis for the safety and efficacy of CT-guided biopsy
Scientific Title Retrospective analysis for the safety of maneuver and the comparison between the image evaluation, the pathological findings, and the final diagnosis, among patients for whom CT-guided biopsy is performed.
Scientific Title:Acronym Retrospective analysis for the safety and efficacy of CT-guided biopsy
Region
Japan

Condition
Condition lung cancer, mediastinal tumor, metastatic lung tumor
Classification by specialty
Pneumology Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and the efficacy of CT-guided biopsy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the complications are evaluated.
We also evaluate the comparison between the diagnosis from biopsy and the final diagnosis.
To compare the diagnoses, we examine the evaluation of images by radiologists, the pathological evaluation from the biopsy specimen, and the final diagnosis.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. patients diagnosed as an lung disease or an mediastinal disease, who received some treatment in Keio University Hospital from 1990.
2. patients who received the CT-guided lung biopsy in Keio University Hospital in 2002.
Key exclusion criteria Patients have no favor to attend this research.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yotaro Izumi
Organization Keio University School of medicine
Division name Division of general thoracic surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of medicine
Division name Division of general thoracic surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Keio University School of medicine
Institute
Department

Funding Source
Organization Keio 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
2012 Year 01 Month 17 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 Enrolling by invitation
Date of protocol fixation
2011 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We analyze the safety and efficacy of CT-guided biopsy.

Management information
Registered date
2012 Year 01 Month 17 Day
Last modified on
2012 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008351

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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