UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027922 |
|---|---|
| Receipt number | R000031983 |
| Scientific Title | Mulutiinstitutional study of Rapid-immunochemihistry (R-IHC) for lung tumor intraoperative diagnosis |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2025/01/06 22:22:46 |
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Basic information
Public title
Mulutiinstitutional study of Rapid-immunochemihistry (R-IHC) for lung tumor intraoperative diagnosis
Acronym
Mulutiinstitutional study of Rapid-immunochemihistry (R-IHC) for lung tumor intraoperative diagnosis
Scientific Title
Mulutiinstitutional study of Rapid-immunochemihistry (R-IHC) for lung tumor intraoperative diagnosis
Scientific Title:Acronym
Mulutiinstitutional study of Rapid-immunochemihistry (R-IHC) for lung tumor intraoperative diagnosis
Region
| Japan |
Condition
Condition
lung tumor
Classification by specialty
| Chest surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validate the usefulness of Rapid Immunohistchemistry staining Device (R-IHC) in intraoperative diagnosis of lung tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy of Rapid Immunohistchemistry staining Device (R-IHC)
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
Lung tumor case requiring rapid intraoperative diagnosis
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Minamiya |
Organization
Akita university
Division name
Department of thoracic surgery
Zip code
010-8543
Address
Hondo 1-1-1, Akita city, Akita, Japan
TEL
018-884-6132
minamiya@jd6.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Konno |
Organization
Akita university
Division name
Department of thoracic surgery
Zip code
010-8543
Address
Hondo 1-1-1, Akita city, Akita, Japan
TEL
018-884-6132
Homepage URL
konno-h@gipc.akita-u.ac.jp
Sponsor or person
Institute
Department of thoracic surgery, Akita university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe university, Iwate medical university, Tokyo medical university, Sndai kousei hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita university
Address
Hondo 1-1-1, Akita city, Akita, Japan
Tel
018-884-6028
soken@hos.akita-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
秋田大学病院（秋田県）、神戸大学病院（兵庫県）、岩手医科大学病院（岩手県）、東京医科大学病院（東京都）、仙台厚生病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/cas.15616
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/cas.15616
Number of participants that the trial has enrolled
169
Results
No false diagnoses of malignancy were rendered in any of the cases when using simple H&E staining. With H&E staining alone, the overall definitive diagnosis rate,
the rate of defined tumor origin, and the rate of determined histological type were 76.92%, 85.80%, and 90.53%, respectively. When rapid IHC was added, those rates
were significantly improved to 88.76%, 94.67%, and 91.72%, respectively.
Results date posted
| 2025 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
In total, 173 specimens (including two each from patients with multiple cancers) were collected at the abovementioned institutes from 169 patients with undiagnosed pulmonary tumors.
At the three institutes, pulmonary tumor samples were collected through core needle biopsy and/or surgery to determine subsequent surgical procedures.
Participant flow
Patients with preoperatively undetermined lung tumors who were scheduled for intraoperative rapid diagnosis were enrolled.
All patients were informed consent was obtained.
Adverse events
None
Outcome measures
The aim of this study was to evaluate the clinical reliability of a new rapid- IHC technique for intraoperative diagnosis of pulmonary tumors.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Patients' recruitment and analysis completed.
The results were accepted for submission to the paper and published.
Management information
Registered date
| 2017 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031983
