UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048400 |
|---|---|
| Receipt number | R000055088 |
| Scientific Title | Feasibility study about establishment of Intraoperative Margin Assessment with "Click-to-sense" (CTS) method using live cells of breast tissues in Breast-Conserving Surgery for primary breast cancer in multicenter clinical trial. |
| Date of disclosure of the study information | 2022/07/18 |
| Last modified on | 2022/07/18 20:11:33 |
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Basic information
Public title
Feasibility study about establishment of Intraoperative Margin Assessment with "Click-to-sense" (CTS) method using live cells of breast tissues in Breast-Conserving Surgery for primary breast cancer in multicenter clinical trial.
Acronym
IntaCTS study
Scientific Title
Feasibility study about establishment of Intraoperative Margin Assessment with "Click-to-sense" (CTS) method using live cells of breast tissues in Breast-Conserving Surgery for primary breast cancer in multicenter clinical trial.
Scientific Title:Acronym
IntaCTS study
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We are going to do a prospective multicenter clinical trial confirming the feasibility of imprinted cell diagnosis using the CTS method including intraoperative assessment of resection stumps for breast conserving surgery (BCS) with breast cancer. The aim of this trial is investigated whether CTS method demonstrate non-inferiority to histological diagnosis of frozen sections in clinical practice. We will try to confirm the concordance rate (correct diagnosis rate) and specificity (false positive rate) in between CTS method and permanent pathological diagnosis.
Basic objectives2
Others
Basic objectives -Others
t would be useful to consider applying automatic deep learning and AI algorithms as a diagnostic tool in CTS imaging diagnosis. At the Department of Information Science, Osaka University, AI would automatically and rapidly evaluate cancer margins.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
1) The feasibility of the CTS method will be confirmed by confirming the achievement rate for the diagnostic results of the CTS method by the multicenter clinical trial.
2)CTS method demonstrate non-inferiority to histological diagnosis of frozen sections in clinical practice. We will try to confirm the concordance rate (correct diagnosis rate) and specificity (false positive rate) in between CTS method and permanent pathological diagnosis.
Key secondary outcomes
1) We will try to confirm the concordance rate (correct diagnosis rate) and specificity (false positive rate) in between intraopetative pathological diagnosis of frozen section. and permanent pathological diagnosis.
2) We will try to confirm that additional intraoperative stump resection and the operation by positive postoperative histopathological diagnosis (by permanent specimen section) Confirm the presence or absence of additional treatment (reoperation / Boost radiation therapy) in the multicenter clinical trial.
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
Female
Key inclusion criteria
1)Primary breast cancer patients (Tis-T2N0-1M0, stage0-IIB) who are indicated for breast-conserving surgery in the multicenter institutes.
2)Those ages are 20 years or over at those registration.
3)Those informed consent as to the study are obtained from each patient before surgery.
Key exclusion criteria
1)Breast cancer patients with a tumor size of 5 cm over (T3 or T4), or with distant metastasis (M1)
2)Those ages are 20 years or over at those registration.
3)Those informed consent as to the study are not obtained from each patient before surgery.
4) Breast cancer patients not to be judged inappropriate by those physicians.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Tanei |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Breast and Endocrine Surgery
Zip code
565-0871
Address
2-2-E10 Yamadaoka, Suita, Osaka
TEL
0668793772
ttanei@onsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Tanei |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Breast and Endocrine Surgery
Zip code
565-0871
Address
2-2-E10 Yamadaoka, Suita, Osaka
TEL
0668793772
Homepage URL
ttanei@onsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka University,Department of Breast and Endocrine Surgery
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant
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
Osaka University Clinical Research Review Committee
Address
2-2-InnovationCenter 4th floor, Yamadaoka, Suita, Osaka
Tel
0662108296
rinri@hp-crc.med.osaka-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
大阪大学医学部附属病院（大阪府）、大阪府立病院機構大阪国際がんセンター（大阪府）、大阪警察病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 18 | 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
| 2021 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1
Management information
Registered date
| 2022 | Year | 07 | Month | 18 | Day |
Last modified on
| 2022 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055088
