Breast CancerPUMPNCT04689529
Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer
A study testing Preoperative imaging study in people with Breast Cancer and Surgery, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer, Surgery, IMAGE
- What is being tested?
- Preoperative imaging study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: The Percentage of Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer Patients Who Underwent Neoadjuvant Chemotherapy
- 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.
Read the 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.
- Conditions
- Breast Cancer, Surgery, IMAGE, Chemotherapy Effect
- Being tested
- Preoperative imaging study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative imaging studyDiagnostic test
MRI, Breast ultrasound sonography, mammography
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy | Experimental | Patients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) after receiving neoadjuvant chemotherapy Receives: Diagnostic Test: Preoperative imaging study |
| Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy | Active comparator | 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. Receives: Diagnostic Test: Preoperative imaging study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final pathology report
Comparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start23 Mar 2018
- Primary completion30 Jun 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wonshik Han, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689529
- Sponsor's protocol ID
- 1711-048-898
- Acronym
- PUMP
- Status last verified
- Jun 2023
- First submitted
- 27 Dec 2020
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Percentage of Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer Patients Who Underwent Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04689529
- Acronym / sponsor ID
- PUMP / 1711-048-898
- Conditions
- Breast Cancer, Surgery, IMAGE, Chemotherapy Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy | Experimental | Diagnostic Test: Preoperative imaging studyPatients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) after receiving neoadjuvant chemotherapy |
| Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy | Active comparator | Diagnostic Test: Preoperative imaging studyPatients 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative imaging studyMRI, Breast ultrasound sonography, mammography | Diagnostic test | Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy, Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy |
Primary outcome
Final pathology report
Time frame: 2 weeks after surgery
Comparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative imaging study in people with Breast Cancer and Surgery, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final pathology report (time frame: 2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.