Multicenter study about Intraoperative Margin Assessment with CTS method for primary breast cancer.

JRCT ID: jRCT1050230207

Registered date:20/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 20/03/2024
• Target sample size: 130
• Study type: Observational

Outcome(s)

• Primary Outcome: In the multi-center collaborative trials, the diagnostic results of the CTS method in the control group will be compared with those obtained from the CTS method in the multi-center collaborative trials, encompassing both margin stump tissue and central tissue specimens. This aims to ascertain the diagnostic accuracy of the CTS method against postoperative histopathological tissue diagnosis (based on permanent specimen sections), including measures of positive concordance rate, negative concordance rate, and overall concordance rate. Additionally, the superiority of the CTS method's diagnostic accuracy over historical controls for intraoperative rapid pathological diagnosis using frozen sections (with approximately typical diagnostic accuracy rates of 80.0% for positive concordance, 95.0% for negative concordance, and 90.0% for overall concordance) will be evaluated. Furthermore, subgroup analyses will be conducted to assess the diagnostic accuracy (including positive concordance rate, negative concordance rate, and overall concordance rate) specifically for margin stump tissue in the control group and for cases undergoing preoperative medical therapy, aiming to identify any trends.

Secondary Outcome

1)Regarding the control group in multi-center collaborative trials, we will examine the diagnostic accuracy of intraoperative pathological tissue diagnosis in actual clinical settings (inclusive of both distal tissue and central tissue specimens diagnosed using frozen section slides) against postoperative histopathological tissue diagnosis (based on permanent specimen sections), including measures of positive concordance rate, negative concordance rate, and overall concordance rate. We will assess the non-inferiority of the diagnostic accuracy of the CTS method against the diagnostic accuracy of intraoperative pathological diagnosis using frozen sections.
2)In relation to the diagnostic results of the CTS method from multi-center collaborative trials and the intraoperative pathological tissue diagnosis results in actual clinical settings (based on frozen section slides), we will verify the presence or absence of intraoperative additional excision of breast tissue, as well as the necessity for postoperative additional treatment (reoperation or boost radiotherapy) based on positive findings in postoperative histopathological tissue diagnosis (based on permanent specimen sections).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Each facility will target patients who meet all the criteria below for eligibility for breast-conserving surgery in primary breast cancer patients (Tis-T2N0-1M0, stages 0-IIB).
1) TNM classification: Tis-T2, N0-1, M0 (based on the 4.1 clinical staging).
2) Age at registration must be 20 years or older (minors are excluded).
3) Patients who have undergone preoperative systemic therapy for breast cancer by the time of registration are also eligible. Cases involving preoperative systemic therapy (such as neoadjuvant chemotherapy or hormone therapy) will be categorized as Group B.
4) Informed consent for trial participation has been obtained from the patient themselves, as the informed consent document.

Exclude criteria

The following criteria will excluded patients eligible for targeting:
1) TNM classification: Breast cancer with a tumor diameter exceeding 5 cm (T3 or higher), or breast cancer with metastasis to other organs M0 (as per the 4.1 clinical staging).
2) Age at registration is below 20 years.
3) Breast cancer patients for whom consent for trial participation has not been obtained from the patient themselves as outlined in the explanatory document.
4) Breast cancer patients deemed unsuitable by their attending physician.

Related Information

• Primary Sponsor: Tanei Tomonori
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED),Grants-in-Aid for Scientific Research (KAKEN)