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.

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. - IntaCTS study

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048400

Enrollment

210

Registered

2022-07-18

Start date

2022-01-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactTomonori Tanei

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

ttanei@onsurg.med.osaka-u.ac.jp0668793772

Outcome results