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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04689529
Other study ID # 1711-048-898
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 23, 2018
Est. completion date December 31, 2023

Study information

Verified date June 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

- The surgical method for breast cancer is determined according to the size and location of the remaining lesions after prior chemotherapy. - There are many patients who were able to undergo partial resection when confirming the final results of patients who underwent total resection after prior chemotherapy. - Therefore, we would like to investigate whether it is effective to make decisions based on the results of pre-operative tests after prior chemotherapy.


Description:

In a study published by Jennifer F. et al., sensitivity to lesions remaining after prior chemotherapy of breast magnetic resonance imaging was measured as 83%, specificity 47%, PPV 47%, NPV 83%, and accuracy 74%. have. Most of the preoperative examinations after prior chemotherapy have the most confidence in the results of breast magnetic resonance imaging, but there will be other factors to predict this result as there will be differences in the actual postoperative pathology results. . After prior chemotherapy, total resection was performed, and cases where partial resection is possible in the postoperative pathologic results are prospectively identified and compared and analyzed.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 360
Est. completion date December 31, 2023
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Breast cancer patients over 20 years of age undergoing surgery at Seoul National University Hospital - Patients to undergo total mastectomy - Patients who received neoadjuvant chemotherapy and undergoing total mastectomy were the main subjects, but as a control group, patients who did not receive neoadjuvant chemotherapy but undergoing total mastectomy were included as subjects. Exclusion Criteria: - In case of total mastectomy at the request of the patient - Except for cases where total resection is performed regardless of size because it is a lesion under the areola and is close to the nipple.

Study Design


Intervention

Diagnostic Test:
Preoperative imaging study
MRI, Breast ultrasound sonography, mammography

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Jongno-gu

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Final pathology report Comparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results 2 weeks after surgery
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