Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer

NCT ID: NCT06876610

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-15

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Screening

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* With confirmed pathological diagnosis and molecular subtyping results
* Ability to provide a written informed consent

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Geneplus-Beijing Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Ruiqi Zhong

Role: primary

+86-10-13501076800

Other Identifiers

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25/071-5017

Identifier Type: -

Identifier Source: org_study_id

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