Breast CancerNCT06016790
Exploring a Breast Cancer Early Screening Model Based on cfDNA
An observational study of Breast Cancer and Breast Fibroadenoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 8 sites in China.
Trial summary
The goal of this observational study is to use cfDNA multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer, Breast Fibroadenoma, Breast Hypoplasia
- What is being tested?
- cfDNA sequencing
- How many people
- 839 participants
- Where
- 8 sitesChina
- Study dates
- 11 Apr 2023to 31 Oct 2024
- How long will I take part?
- 3 Days
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients and patients with benign breast diseases.
Who may be able to join
- Patients ≥18 years old and ≤70 years old;
- Plasma of the participant can be obtained;
- Willing to sign the informed consent;
- Meet one of the following criteria:
- 4.1)Patients diagnosed with invasive breast cancer or carcinoma in situ of the breast for the first time; 4.2)Patients with breast fibroma or breast adenosis and breast fibrocystic hyperplasia;
Who cannot join
- In any of the following situations, subjects should not participate in the trial:
- Pregnant or lactating;
- Unable to obtain the participant's plasma;
- Patients with other types of malignant tumors diagnosed by pathology within 5 years before enrollment;
- The patients had suspected imaging (B-ultrasound, CT, etc.) of other malignant tumors within the past 1 year after enrollment, but no pathological confirmation;
- Received any blood product transfusion in the past 30 days;
- Participants considered by the investigator to be inappropriate to participate in this research-type clinical trial.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000
Affiliated Hangzhou First People's Hospital ,Westlake University School of Medicine
Hangzhou, Zhejiang, 310000
Sir Run Run Shaw Hospital Affiliated With Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Wenhui Community Health Service center, Gongshu district, Hangzhou city
Hangzhou, Zhejiang, 310000
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
Zhejiang Provincial Hospital Of Traditional Chinese Medicine
Hangzhou, Zhejiang, 310000
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315046
About this study
Official title: Scientific Research on Exploring a Breast Cancer Early Screening Model Using cfDNA Multi-omics Liquid Biopsy Technology Based on Deep Learning
The goal of this observational study is to use cfDNA multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. The main questions it aims to answer are:
- Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
- Evaluate participants' TeFei™ score Participants will be collected peripheral venous blood before surgery or systemic treatment. The blood will then be sent to the collaboration company for sequencing. The collaboration company will analyze the sequencing results and build a cfDNA multi-omics signature library. Finally, the collaboration company will use deep learning algorithms to train and optimize the feature library.
Researchers will compare the cancer group with a benign control group to determine the model's effectiveness in differentiating between them.
- Conditions
- Breast Cancer, Breast Fibroadenoma, Breast Hypoplasia
- Being tested
- cfDNA sequencing
- Keywords
- cfDNA, Deep learning
- Medical subject headings
- Breast Neoplasms, Fibroadenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cfDNA sequencingGenetic
Multi-omics sequencing of cfDNA in peripheral venous blood.
| Study group | Role | What they receive |
|---|---|---|
| the cancer group | 503 cases of early breast cancer Receives: Genetic: cfDNA sequencing | |
| the benign control group | 289 cases of control group Receives: Genetic: cfDNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
Peripheral blood samples were collected during routine physical examinations for healthy volunteers and prior to surgery for cancer patients. The blood samples were drawn and placed into cfDNA preservation tubes (Ardent BioMed, Guangdong, China, Cat. # BY10240301). After collection, the fresh blood was subjected to an initial centrifugation at 1,600 × g for 10 minutes at 4°C, allowing the plasma supernatant to be carefully separated via pipetting. This plasma was then centrifuged again at 16,000 × g for 10 minutes at 4°C to remove any residual debris. The resulting plasma supernatant was then carefully collected and stored at -80°C. The preserved plasma samples were subsequently transported on dry ice to the central laboratory at OmixScience Research Institute (Hangzhou, China).
Measured: 1 year from enrollment
Secondary outcomes (1)
Evaluate participants' TeFei™ score
This test is based on the expression level of key genes in the cfDNA tumor of the participant's blood sample, and the relative expression level of these genes is calculated to obtain a score. This score is called the TeFei™ Score and usually ranges from 0 to 100, with a higher score indicating a higher tumor burden in the patient.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start11 Apr 2023
- Primary completion13 Dec 2023
- Study completion31 Oct 2024
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 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 839 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- OmixScience Institute
- Responsible party
- Principal investigator, Ni Chao, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Chao Ni, Principal investigator, Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016790
- Sponsor's protocol ID
- ZE-OMIX-001
- Status last verified
- Jan 2025
- First submitted
- 22 Aug 2023
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the database is related to the products of the cooperative company, in order to protect the intellectual property rights of the cooperative company, IPD will not be shared.
Publications
Mathios D, Johansen JS, Cristiano S, Medina JE, Phallen J, Larsen KR, Bruhm DC, Niknafs N, Ferreira L, Adleff V, Chiao JY, Leal A, Noe M, White JR, Arun AS, Hruban C, Annapragada AV, Jensen SO, Orntoft MW, Madsen AH, Carvalho B, de Wit M, Carey J, Dracopoli NC, Maddala T, Fang KC, Hartman AR, Forde PM, Anagnostou V, Brahmer JR, Fijneman RJA, Nielsen HJ, Meijer GA, Andersen CL, Mellemgaard A, Bojesen SE, Scharpf RB, Velculescu VE. Detection and characterization of lung cancer using cell-free DNA fragmentomes. Nat Commun. 2021 Aug 20;12(1):5060. doi: 10.1038/s41467-021-24994-w.
PubMed 34417454
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Research on Exploring a Breast Cancer Early Screening Model Using cfDNA Multi-omics Liquid Biopsy Technology Based on Deep Learning
- ClinicalTrials.gov ID
- NCT06016790
- Acronym / sponsor ID
- ZE-OMIX-001
- Conditions
- Breast Cancer, Breast Fibroadenoma, Breast Hypoplasia
- Keywords
- cfDNA, Deep learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 839 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- OmixScience Institute
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 30 Aug 2023 (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 goal of this observational study is to use cfDNA multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. The main questions it aims to answer are:
- Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
- Evaluate participants' TeFei™ score Participants will be collected peripheral venous blood before surgery or systemic treatment. The blood will then be sent to the collaboration company for sequencing. The collaboration company will analyze the sequencing results and build a cfDNA multi-omics signature library. Finally, the collaboration company will use deep learning algorithms to train and optimize the feature library.
Researchers will compare the cancer group with a benign control group to determine the model's effectiveness in differentiating between them.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the cancer group | – | Genetic: cfDNA sequencing503 cases of early breast cancer |
| the benign control group | – | Genetic: cfDNA sequencing289 cases of control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients and patients with benign breast diseases.
Key inclusion criteria (5 listed)
- Patients ≥18 years old and ≤70 years old;
- Plasma of the participant can be obtained;
- Willing to sign the informed consent;
- Meet one of the following criteria:
- 4.1)Patients diagnosed with invasive breast cancer or carcinoma in situ of the breast for the first time; 4.2)Patients with breast fibroma or breast adenosis and breast fibrocystic hyperplasia;
Key exclusion criteria (7 listed)
- Pregnant or lactating;
- Unable to obtain the participant's plasma;
- Patients with other types of malignant tumors diagnosed by pathology within 5 years before enrollment;
- The patients had suspected imaging (B-ultrasound, CT, etc.) of other malignant tumors within the past 1 year after enrollment, but no pathological confirmation;
- Received any blood product transfusion in the past 30 days;
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 |
|---|---|---|
| cfDNA sequencingMulti-omics sequencing of cfDNA in peripheral venous blood. | Genetic | the benign control group, the cancer group |
Primary outcome
Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
Time frame: 1 year from enrollment
Peripheral blood samples were collected during routine physical examinations for healthy volunteers and prior to surgery for cancer patients. The blood samples were drawn and placed into cfDNA preservation tubes (Ardent BioMed, Guangdong, China, Cat. # BY10240301). After collection, the fresh blood was subjected to an initial centrifugation at 1,600 × g for 10 minutes at 4°C, allowing the plasma supernatant to be carefully separated via pipetting. This plasma was then centrifuged again at 16,000 × g for 10 minutes at 4°C to remove any residual debris. The resulting plasma supernatant was then carefully collected and stored at -80°C. The preserved plasma samples were subsequently transported on dry ice to the central laboratory at OmixScience Research Institute (Hangzhou, China).
1 secondary outcome
Evaluate participants' TeFei™ score
Time frame: 60 days
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 29 Jul 2025.
- Results publication: PubMed 34417454Mathios D, Johansen JS, Cristiano S, Medina JE, Phallen J, Larsen KR, Bruhm DC, Niknafs N, Ferreira L, Adleff V, Chiao JY, Leal A, Noe M, White JR, Arun AS, Hruban C, Annapragada AV, Jensen SO, Orntoft MW, Madsen AH, Carvalho B, de Wit M, Carey J, Dracopoli NC, Maddala T, Fang KC, Hartman AR, Forde PM, Anagnostou V, Brahmer JR, Fijneman RJA, Nielsen HJ, Meijer GA, Andersen CL, Mellemgaard A, Bojesen SE, Scharpf RB, Velculescu VE. Detection and characterization of lung cancer using cell-free DNA fragmentomes. Nat Commun. 2021 Aug 20;12(1):5060. doi: 10.1038/s41467-021-24994-w.
- Individual participant dataSharing planned: No. Because the database is related to the products of the cooperative company, in order to protect the intellectual property rights of the cooperative company, IPD will not be shared.
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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.
Chao Ni principal investigator
Second Affiliated Hospital of Zhejiang University School of Medicine
8 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 and Breast Fibroadenoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 8 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 5 inclusion and 7 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Evaluate the sensitivity and specificity of the early detection model for breast cancer screening (time frame: 1 year from enrollment). 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 NCT06016790, 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 29 Jul 2025.