UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054899 |
|---|---|
| Receipt number | R000061469 |
| Scientific Title | Development of an intraoperative rapid immunohistochemistry with non-contact alternating-current electric-field mixing |
| Date of disclosure of the study information | 2024/07/06 |
| Last modified on | 2024/07/06 10:48:17 |
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Basic information
Public title
Development of an intraoperative rapid immunohistochemistry with non-contact alternating-current electric-field mixing
Acronym
Rapid immunohistochemistry with alternating-current electric-field mixing
Scientific Title
Development of an intraoperative rapid immunohistochemistry with non-contact alternating-current electric-field mixing
Scientific Title:Acronym
Rapid immunohistochemistry with alternating-current electric-field mixing
Region
| Japan |
Condition
Condition
Malignant tumor (or suspected malignancy)
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The present study aims to evaluate the clinical reliability of novel rapid immunohistochemistry with a non-contact alternating-current electric-field mixing technique (Histo-Teq R-IHC or Auto) for intraoperative frozen-section diagnosis in patients with malignant tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of rapid immunohistochemistry with a non-contact alternating-current electric-field mixing
Key secondary outcomes
Accuracy of the combination of histology and molecular pathology by rapid immunohistochemistry with a non-contact alternating-current electric-field mixing
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
Prospective study (1); Patients diagnosed with a malignant tumor (or suspected malignancy) who explained to the person using the explanation consent document and obtained written consent
Retrospective study (2); Patients diagnosed with a malignant tumor (or suspected malignancy) who have residual paraffin-embedded blocks collected in the past and can be immunohistochemically stained.
Key exclusion criteria
(1) Patients who are unable to obtain written consent from the individual to participate in the research
(2) Patients who have opted out and have requested not to participate in the research
Target sample size
2200
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Imai |
Organization
Akita University Hospital
Division name
Thoracic Surgery
Zip code
010-8543
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6132
karo@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Imai |
Organization
Akita University Hospital
Division name
Thoracic Surgery
Zip code
010-8543
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6132
Homepage URL
karo@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Akita University Graduate 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
Akita University Clinical Research Promotion and Support Center
Address
1-1-1 Hondo, AKita, Japan
Tel
018-884-6216
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Intraoperative frozen section diagnosis using hematoxylin and eosin (HE) staining has traditionally been used to assess indeterminate pulmonary lesions and guide surgical management. However, a considerable limitation to this approach is that there is a 2-13.1% false-negative rate and a 0-0.2% false-positive rate among frozen section diagnoses as compared to diagnoses made with post formalin-fixed, paraffin-embedded tissue blocks. This is because frozen sections of lung tissue can be difficult to accurately interpret due to severe distortion of the tissue architecture, ice crystal formation, and collapse of the alveolar spaces during cryosection. Nodules less than 1 cm in size can be very difficult to accurately diagnose with HE-stained frozen sections alone, especially when the tumor is poorly differentiated. By contrast, immunohistochemistry (IHC) is a reliable screening and molecular analysis method. Up to now, however, use of IHC for intraoperative frozen section diagnosis has not been possible because IHC involves time-consuming and skilled processing.
To overcome that limitation, we have been developing a rapid immunohistochemistry (rapid-IHC) method that makes use of an alternating current (AC) electric field to facilitate the antigen-antibody reaction by stirring the diluted solution on the sections without a stirrer through recurrent transformation of the microdroplet's shape (AC mixing). The resultant AC mixing achieves more stable staining and accurate diagnosis/molecular analysis by increasing the opportunity for contact between the antigen and antibody, irrespective of the antibody type. This rapid-IHC technique enables prompt, stable detection of target cells within frozen sections and can provide a surgeon with an intraoperative diagnosis within a minimum of 13 min, as opposed to the 3-6 hours required for conventional IHC.
Management information
Registered date
| 2024 | Year | 07 | Month | 06 | Day |
Last modified on
| 2024 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061469
