PUMP: Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04689529
Collaborator
(none)
460
1
2
57.3
8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Preoperative imaging study
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
460 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Percentage of Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer Patients Who Underwent Neoadjuvant Chemotherapy
Actual Study Start Date :
Mar 23, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy

Patients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) after receiving neoadjuvant chemotherapy

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

Active Comparator: Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy

Patients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) even in patients who did not receive neoadjuvant chemotherapy as a control group.

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

Outcome Measures

Primary Outcome Measures

  1. Final pathology report [2 weeks after surgery]

    Comparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Jongno-gu Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wonshik Han, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04689529
Other Study ID Numbers:
  • 1711-048-898
First Posted:
Dec 30, 2020
Last Update Posted:
Feb 15, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2022