Breast CancerNCT04483804
Application of Radiomics in Breast Cancer
An observational study of Breast Cancer and Ultrasound, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Little is known about the correlation between ultrasound characteristics (conventional, elastography and contrast enhanced ultrasound (CEUS) )and pathological prognostic factors in breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer, Ultrasound, Elastography
- What is being tested?
- Endocrine therapy
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with breast cancer
Who may be able to join
- Clinical diagnosis of breast cancer
Who cannot join
- Missing pathology Missing follow-up results Missing data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital Zhejiang University School of Medicine
Hanzhou, Zhejiang, 310009
zimei Lin, +86151517171799, zimei.lin@zju.edu.cn
jifan Chen, +8613605771565, jifanchen@zju.edu.cn
About this study
Official title: Application of Radiomics in Correlation Between Ultrasound Characteristics and Pathological Prognostic Factors in Breast Cancer
Little is known about the correlation between ultrasound characteristics (conventional, elastography and contrast enhanced ultrasound (CEUS) )and pathological prognostic factors in breast cancer. The aim of this study was to explore the correlation between ultrasound characteristics and pathological prognostic factors using radiomics.
- Conditions
- Breast Cancer, Ultrasound, Elastography, Pathology, Radiomics
- Being tested
- Endocrine therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocrine therapyCombination product
Endocrine therapy
| Study group | Role | What they receive |
|---|---|---|
| disease free survival | Time from randomization to relapse or death due to disease progression Receives: Combination Product: Endocrine therapy | |
| non-disease free survival | Time of metastasis or death Receives: Combination Product: Endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
metastasis
lymph node metastasis and/or distant metastasis
Measured: through study completion, an average of 1 year
death
death
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Jan 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2028 (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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- pintong Huang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483804
- Sponsor's protocol ID
- SAHZhejiangU---Breast
- Status last verified
- Dec 2022
- First submitted
- 13 May 2020
- Last updated
- 10 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data (IPD) can be shared after the main unit publish articles
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Radiomics in Correlation Between Ultrasound Characteristics and Pathological Prognostic Factors in Breast Cancer
- ClinicalTrials.gov ID
- NCT04483804
- Acronym / sponsor ID
- SAHZhejiangU---Breast
- Conditions
- Breast Cancer, Ultrasound, Elastography, Pathology, Radiomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Jul 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.
Little is known about the correlation between ultrasound characteristics (conventional, elastography and contrast enhanced ultrasound (CEUS) )and pathological prognostic factors in breast cancer. The aim of this study was to explore the correlation between ultrasound characteristics and pathological prognostic factors using radiomics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| disease free survival | – | Combination Product: Endocrine therapyTime from randomization to relapse or death due to disease progression |
| non-disease free survival | – | Combination Product: Endocrine therapyTime of metastasis or death |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with breast cancer
Key inclusion criteria (1 listed)
- Clinical diagnosis of breast cancer
Key exclusion criteria (1 listed)
- Missing pathology Missing follow-up results Missing data
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 |
|---|---|---|
| Endocrine therapyEndocrine therapy | Combination product | disease free survival, non-disease free survival |
Primary outcome
metastasis
Time frame: through study completion, an average of 1 year
lymph node metastasis and/or distant metastasis
death
Time frame: through study completion, an average of 1 year
death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: Yes. individual participant data (IPD) can be shared after the main unit publish articles
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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.
pintong Huang principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 and Ultrasound, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Mar 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zimei Lin (+8615157171799, zimei.lin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metastasis (time frame: through study completion, an average of 1 year). 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?
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 10 Mar 2023.