Breast CancerNCT04360616
The Diagnosis and Prognosis of Nonpalpable Breast Cancer Detected by the US vs Mammography: a Clinical Noninferiority Trial.
An observational study of Breast Cancer, run by The First Affiliated Hospital of the Fourth Military Medical University at 1 site in China.
Trial summary
To evaluate and compare the sensitivity, specificity, AUC, pathology results of core needle biopsy and surgical pathology results coincidence rate, tumor staging, and DFS (disease-free survival) of US-detected nonpalpable breast cancer vs mammography-detected nonpalpable breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- imaging
- How many people
- 1,277 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Mar 2023
- Phase
- Observational
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: Female patients over 18 years old from China
Who may be able to join
- Women aged 18 years and over with full capacity for civil conduct;
- Breast imaging examination (including mammography and breast ultrasound) found that patients with BI-RADS 4 or nonpalpable lesion need to have breast biopsy (refer to the classification of BI-RADS, which is consistent with the indications for biopsy), including some patients with BI-RADS 3 nonpalpable breast lesions who are willing to have biopsy;
- Voluntarily participate in and sign the informed consent form, and be willing to accept the inspection designated by this test;
- The results of blood examination, coagulation examination, preoperative infection examination, and 12 lead ECG examination within 2 weeks before biopsy met the biopsy requirements;
- It conforms to the biopsy standard (refer to the image-guided breast histology biopsy guide in the breast cancer diagnosis and treatment guide and specification of China Anti Cancer Association (2019 version)).
Who cannot join
- Women are participating in another clinical trial of drug or medical device;
- Women with neuropsychiatric disorders;
- Women with severe systemic diseases and serious bleeding diseases that can not cooperate with the examination, or the researchers think it is not suitable to participate in this clinical trial;
- Other subjects not suitable for X-ray examination
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fourth Military Medical University
Xi'an, Shaanxi, 710000
hongping song, Ph.D, +86-29-84771663, Songhp@fmmu.edu.cn
hongping song
About this study
Official title: The Diagnosis and Prognosis of Nonpalpable Breast Cancer Detected by the Ultrasound vs Mammography: a Clinical Noninferiority Trial.
To evaluate and compare the sensitivity, specificity, AUC, pathology results of core needle biopsy and surgical pathology results coincidence rate, tumor staging, and DFS (disease-free survival) of US-detected nonpalpable breast cancer vs mammography-detected nonpalpable breast cancer.
- Conditions
- Breast Cancer
- Being tested
- imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagingDiagnostic test
perform US and mammography examination
| Study group | Role | What they receive |
|---|---|---|
| MG+ | the lesion could detected by mammography Receives: Diagnostic Test: imaging | |
| US+ | the lesion could detected by breast ulrtasound Receives: Diagnostic Test: imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitive
Proportion of corrected-detected malignant lesions by the US or MG
Measured: 3 days
Specificity
Proportion of corrected-detected benign lesions by the US or MG
Measured: 3 days
Area under curve
Area under receiver operating characteristic (ROC) curve in percentage (%)
Measured: 3 days
Disease-free survival (DFS)
The time that the patient is free of the signs and symptoms of a disease after treatment.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Apr 2020
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,277 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of the Fourth Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Hongping, The First Affiliated Hospital of the Fourth Military Medical University
- Investigators
- Hongping Song, MD, Principal investigator, Xijing hospital of The fourth military medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360616
- Sponsor's protocol ID
- US-MAM
- Status last verified
- Jan 2022
- First submitted
- 22 Apr 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnosis and Prognosis of Nonpalpable Breast Cancer Detected by the Ultrasound vs Mammography: a Clinical Noninferiority Trial.
- ClinicalTrials.gov ID
- NCT04360616
- Acronym / sponsor ID
- US-MAM
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,277 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of the Fourth Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 24 Apr 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.
To evaluate and compare the sensitivity, specificity, AUC, pathology results of core needle biopsy and surgical pathology results coincidence rate, tumor staging, and DFS (disease-free survival) of US-detected nonpalpable breast cancer vs mammography-detected nonpalpable breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MG+ | – | Diagnostic Test: imagingthe lesion could detected by mammography |
| US+ | – | Diagnostic Test: imagingthe lesion could detected by breast ulrtasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Female patients over 18 years old from China
Key inclusion criteria (5 listed)
- Women aged 18 years and over with full capacity for civil conduct;
- Breast imaging examination (including mammography and breast ultrasound) found that patients with BI-RADS 4 or nonpalpable lesion need to have breast biopsy (refer to the classification of BI-RADS, which is consistent with the indications for biopsy), including some patients with BI-RADS 3 nonpalpable breast lesions who are willing to have biopsy;
- Voluntarily participate in and sign the informed consent form, and be willing to accept the inspection designated by this test;
- The results of blood examination, coagulation examination, preoperative infection examination, and 12 lead ECG examination within 2 weeks before biopsy met the biopsy requirements;
- It conforms to the biopsy standard (refer to the image-guided breast histology biopsy guide in the breast cancer diagnosis and treatment guide and specification of China Anti Cancer Association (2019 version)).
Key exclusion criteria (4 listed)
- Women are participating in another clinical trial of drug or medical device;
- Women with neuropsychiatric disorders;
- Women with severe systemic diseases and serious bleeding diseases that can not cooperate with the examination, or the researchers think it is not suitable to participate in this clinical trial;
- Other subjects not suitable for X-ray examination
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 |
|---|---|---|
| imagingperform US and mammography examination | Diagnostic test | MG+, US+ |
Primary outcome
Sensitive
Time frame: 3 days
Proportion of corrected-detected malignant lesions by the US or MG
Specificity
Time frame: 3 days
Proportion of corrected-detected benign lesions by the US or MG
Area under curve
Time frame: 3 days
Area under receiver operating characteristic (ROC) curve in percentage (%)
Disease-free survival (DFS)
Time frame: 3 years
The time that the patient is free of the signs and symptoms of a disease after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
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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.
Hongping Song, MD principal investigator
Xijing hospital of The fourth military medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by The First Affiliated Hospital of the Fourth Military Medical University at 1 site in China.
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 5 inclusion and 4 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 25 Jan 2022. 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 China. 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?
Contact Hongping Song, MD (86 029 84771663, song.hp@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitive (time frame: 3 days). The study lists 4 primary outcomes in all. 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 25 Jan 2022.