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.

Phase 2

Recruiting

• Conditions: Breast Cancer

• Registration Number: JPRN-UMIN000048400
• Lead Sponsor: Graduate School of Medicine, Osaka University,Department of Breast and Endocrine Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-18
• Last Update Posted: 17 October 2023
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.