Breast Cancer ScreeningNCT06876610
Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer
An observational study of Breast Cancer Screening, run by Geneplus-Beijing Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to construct an auxiliary diagnostic model for breast cancer by methylation markers. The study will collect blood and tissue samples from participants with breast cancer and benign disease for whole-genome methylation sequencing. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Breast Cancer Screening
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to 31 Aug 2026
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of breast cancer and benign diseases.
Who may be able to join
- With confirmed pathological diagnosis and molecular subtyping results
- Ability to provide a written informed consent
Who cannot join
- Patients with a history of or currently suffering from other malignancies
- Pregnant or planning to become pregnant female patients
- Patients who have received cancer treatment, including surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy, before blood draw
- Patients with a history of blood transfusion within the past month
- Patients with a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Patients with persistent fever or undergoing anti-inflammatory treatment within 14 days before blood draw
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- Any other conditions that the researcher deems may make the patient unsuitable for inclusion in the study or may interfere with the completion of the study
- Patients in poor physical condition who are not suitable for blood draw
- Patients who cannot provide informed consent or refuse blood draw
- History of malignancies
- Current malignancies or precancerous lesions
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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ruiqi Zhong, +86-10-13501076800, 13501076800@163.com
About this study
The purpose of this study is to construct an auxiliary diagnostic model for breast cancer by methylation markers. The study will collect blood and tissue samples from participants with breast cancer and benign disease for whole-genome methylation sequencing. It will screen methylation markers and develop a methylation auxiliary diagnosis model to distinguish between breast cancer and non-cancer.
- Conditions
- Breast Cancer Screening
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 |
|---|---|---|
| Cancer Arm | Participants with breast cancer from which a tumor tissue will be collected. Participants with new diagnosis of breast cancer from which a blood sample will be collected. | |
| Benign Diseases Arm | Participants with breast benign diseases from which a tissue will be collected. Participants with breast benign diseases from which a blood sample will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish DNA methylation profiles of two populations by collecting tissues and peripheral blood related to benign and malignant breast nodules.
Measured: 12 months
Based on DNA methylation profiles, systematically evaluate the signal, noise, and complementarity of methylation biomarkers and ultimately form a set of diagnostic biomarker combinations for breast malignant nodules.
Measured: 12 months
Further develop a methylation assisted diagnostic model that can effectively distinguish between benign and malignant breast nodules.
Measured: 12 months
Secondary outcomes (1)
Evaluate the contribution and performance of methylation assisted diagnostic models by integrating imaging and methylation assisted diagnostic model results, and clarify the specificity and sensitivity of integrated model diagnosis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ScreeningStudies 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geneplus-Beijing Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876610
- Sponsor's protocol ID
- 25/071-5017
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer
- ClinicalTrials.gov ID
- NCT06876610
- Acronym / sponsor ID
- 25/071-5017
- Conditions
- Breast Cancer Screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Geneplus-Beijing Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 14 Mar 2025 (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 purpose of this study is to construct an auxiliary diagnostic model for breast cancer by methylation markers. The study will collect blood and tissue samples from participants with breast cancer and benign disease for whole-genome methylation sequencing. It will screen methylation markers and develop a methylation auxiliary diagnosis model to distinguish between breast cancer and non-cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Arm | – | –Participants with breast cancer from which a tumor tissue will be collected. Participants with new diagnosis of breast cancer from which a blood sample will be collected. |
| Benign Diseases Arm | – | –Participants with breast benign diseases from which a tissue will be collected. Participants with breast benign diseases from which a blood sample will be collected. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of breast cancer and benign diseases.
Key inclusion criteria (2 listed)
- With confirmed pathological diagnosis and molecular subtyping results
- Ability to provide a written informed consent
Key exclusion criteria (11 listed)
- Patients with a history of or currently suffering from other malignancies
- Pregnant or planning to become pregnant female patients
- Patients who have received cancer treatment, including surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy, before blood draw
- Patients with a history of blood transfusion within the past month
- Patients with a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
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
Establish DNA methylation profiles of two populations by collecting tissues and peripheral blood related to benign and malignant breast nodules.
Time frame: 12 months
Based on DNA methylation profiles, systematically evaluate the signal, noise, and complementarity of methylation biomarkers and ultimately form a set of diagnostic biomarker combinations for breast malignant nodules.
Time frame: 12 months
Further develop a methylation assisted diagnostic model that can effectively distinguish between benign and malignant breast nodules.
Time frame: 12 months
1 secondary outcome
Evaluate the contribution and performance of methylation assisted diagnostic models by integrating imaging and methylation assisted diagnostic model results, and clarify the specificity and sensitivity of integrated model diagnosis.
Time frame: 12 months
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 14 Mar 2025.
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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.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
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 Screening, run by Geneplus-Beijing Co. Ltd. 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 2 inclusion and 11 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 14 Mar 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish DNA methylation profiles of two populations by collecting tissues and peripheral blood related to benign and malignant breast nodules. (time frame: 12 months). The study lists 3 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 14 Mar 2025.