UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015930 |
|---|---|
| Receipt number | R000018543 |
| Scientific Title | Establishment of the technique for histological diagnoses using images gained by micro-computed tomography and assessment for the clinical usefulness |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2024/06/19 16:47:40 |
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Basic information
Public title
Establishment of the technique for histological diagnoses using images gained by micro-computed tomography and assessment for the clinical usefulness
Acronym
Establishment of the technique for histological diagnoses using images gained by micro-computed tomography
Scientific Title
Establishment of the technique for histological diagnoses using images gained by micro-computed tomography and assessment for the clinical usefulness
Scientific Title:Acronym
Establishment of the technique for histological diagnoses using images gained by micro-computed tomography
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate histological diagnoses using images gained by micro-computed tomography and assessment for the clinical usefulness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
concordance rate of histological diagnoses
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
lung cancer patients received pulmonary resection
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toyofumi |
| Middle name | |
| Last name | Yoshikawa |
Organization
Nagoya university
Division name
department of thoracic surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
0527442375
shota197065@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Nakamura |
Organization
Nagoya university hospital
Division name
department of thoracic surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
0527442375
Homepage URL
shota197065@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya university hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel
0527442375
shota197065@med.nagoya-u.ac.jp
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
| 2015 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.med.nagoya-u.ac.jp/kokyuukigeka/abou
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32273629/
Number of participants that the trial has enrolled
50
Results
We found that microCT images could be correctly divided by alveolar walls into normal lung area and lung cancer area. Further detailed investigations with regard to microCT are needed to make comparable histological diagnoses using microCT images with conventional microscopic methods of pathological diagnoses.
Results date posted
| 2024 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Lung cancer patients who underwent surgical resection at our thoracic surgery department
Participant flow
Primary Evaluation Items:
Agreement rate and kappa coefficient of concordance between micro-CT diagnosis (tissue diagnosis based on micro-CT images of formalin-fixed resected lung specimens) and conventional tissue diagnosis (tissue diagnosis based on preparations).
Secondary Evaluation Items:
Agreement rate and kappa coefficient of concordance between micro-CT diagnosis and tissue diagnosis for pleural invasion and vascular invasion.
Statistical Methods:
Agreement rate and kappa coefficient of concordance.
Adverse events
NONE
Outcome measures
To compare the differences between histopathological specimen diagnosis and micro-CT tissue diagnosis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It will be informed by publishing papers
Management information
Registered date
| 2014 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018543
