UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007093 |
|---|---|
| Receipt number | 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 13:45:20 |
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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
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
Sponsor or person
Institute
Keio University School of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008351
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
