UMIN-CTR Clinical Trial

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
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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
Email	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
Email	ttanei@onsurg.med.osaka-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Osaka University,Department of Breast and Endocrine Surgery
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055088