Breast Cancer FemaleNCT03080623
Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
An observational study of Breast Cancer Female and Diagnoses Disease, run by Peking University at 4 sites in China.
Trial summary
This study proposed to construct an ultrasound-based diagnostic model for Differentiating Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and prospective part, which are designed for model construction and independent validation, respectively.This study aims to construct an… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Female, Diagnoses Disease
- How many people
- 1,981 participants
- Where
- 4 sitesChina
- Study dates
- 8 Sep 2018to 31 Dec 2019
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: females with breast lesion who need to receive breast ultrasound to make differential diagnosis of benign and malignant lesion
Who may be able to join
- female
- with single breast lesion(maximum diameter>0.8 cm)
- agree to receive follow-up in six months and take the second breast ultrasound six month after the first breast ultrasound, if a benign diagnosis is achieved at the first ultrasound
- sign the informed consent
Who cannot join
- lost to follow-up
- failed to take the second breast ultrasound six month after the first breast ultrasound
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100142
Haidian women and children's hospital of beijing
Beijing
Shunyi women and children's hospital of Beijing Children's Hospital
Beijing
Fourth Hospital of Heibei Medical Hospital
Shijiazhuang
About this study
This study proposed to construct an ultrasound-based diagnostic model for Differentiating Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and prospective part, which are designed for model construction and independent validation, respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the efficacy of the model for identifying malignant breast lesion from benign lesion, and finally promote the application of this diagnostic model in more clinics.
- Conditions
- Breast Cancer Female, Diagnoses Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspicious breast lesions | women with Suspicious breast lesions, who need to receive breast ultrasound will be collected in this cohort. According to the diagnosis of breast ultrasound，patients will be assigned to breast biopsy or follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast biopsy proved malignant or benign lesion
for patients regarded as malignant by the breast ultrasound, breast biopsy results are used as reference test, which determines the breast lesion is malignant or benign
Measured: between breast ultrasound and biopsy(one week)
two breast ultrasound identified benign lesion
for patients regarded as benign by the breast ultrasound, they will receive a second breast ultrasound after six month(this is regular examination for patients with first detected breast lesion). If the second ultrasound indicates benign, the lesion will be regarded as benign
Measured: between first detection of breast lesion and the second ultrasound(six month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start8 Sep 2018
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,981 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao OUYANG, Peking University
- Investigators
- Tao Ouyang, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080623
- Sponsor's protocol ID
- D161100000816006
- Status last verified
- Oct 2020
- First submitted
- 24 Feb 2017
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huo L, Tan Y, Wang S, Geng C, Li Y, Ma X, Wang B, He Y, Yao C, Ouyang T. Machine Learning Models to Improve the Differentiation Between Benign and Malignant Breast Lesions on Ultrasound: A Multicenter External Validation Study. Cancer Manag Res. 2021 Apr 16;13:3367-3379. doi: 10.2147/CMAR.S297794. eCollection 2021.
PubMed 33889025
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
- ClinicalTrials.gov ID
- NCT03080623
- Acronym / sponsor ID
- D161100000816006
- Conditions
- Breast Cancer Female, Diagnoses Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,981 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 8 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Mar 2017 (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.
This study proposed to construct an ultrasound-based diagnostic model for Differentiating Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and prospective part, which are designed for model construction and independent validation, respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the efficacy of the model for identifying malignant breast lesion from benign lesion, and finally promote the application of this diagnostic model in more clinics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicious breast lesions | – | –women with Suspicious breast lesions, who need to receive breast ultrasound will be collected in this cohort. According to the diagnosis of breast ultrasound，patients will be assigned to breast biopsy or follow-up |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- females with breast lesion who need to receive breast ultrasound to make differential diagnosis of benign and malignant lesion
Key inclusion criteria (4 listed)
- female
- with single breast lesion(maximum diameter>0.8 cm)
- agree to receive follow-up in six months and take the second breast ultrasound six month after the first breast ultrasound, if a benign diagnosis is achieved at the first ultrasound
- sign the informed consent
Key exclusion criteria (2 listed)
- lost to follow-up
- failed to take the second breast ultrasound six month after the first breast ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
breast biopsy proved malignant or benign lesion
Time frame: between breast ultrasound and biopsy(one week)
for patients regarded as malignant by the breast ultrasound, breast biopsy results are used as reference test, which determines the breast lesion is malignant or benign
two breast ultrasound identified benign lesion
Time frame: between first detection of breast lesion and the second ultrasound(six month)
for patients regarded as benign by the breast ultrasound, they will receive a second breast ultrasound after six month(this is regular examination for patients with first detected breast lesion). If the second ultrasound indicates benign, the lesion will be regarded as benign
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Derived from this study: PubMed 33889025Huo L, Tan Y, Wang S, Geng C, Li Y, Ma X, Wang B, He Y, Yao C, Ouyang T. Machine Learning Models to Improve the Differentiation Between Benign and Malignant Breast Lesions on Ultrasound: A Multicenter External Validation Study. Cancer Manag Res. 2021 Apr 16;13:3367-3379. doi: 10.2147/CMAR.S297794. eCollection 2021.
- 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.
Tao Ouyang study chair
Peking University Cancer Hospital & Institute
4 sites 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 Female and Diagnoses Disease, run by Peking University at 4 sites 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 4 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: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
breast biopsy proved malignant or benign lesion (time frame: between breast ultrasound and biopsy(one week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080623, which also lists 1 linked publication.
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 28 Oct 2020.