Exploring a Breast Cancer Early Screening Model Based on cfDNA

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

COMPLETED

Total Enrollment

839 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-11

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Breast Fibroadenoma Breast Hypoplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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the cancer group

503 cases of early breast cancer

cfDNA sequencing

Intervention Type GENETIC

Multi-omics sequencing of cfDNA in peripheral venous blood.

the benign control group

289 cases of control group

cfDNA sequencing

Intervention Type GENETIC

Multi-omics sequencing of cfDNA in peripheral venous blood.

Interventions

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cfDNA sequencing

Multi-omics sequencing of cfDNA in peripheral venous blood.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

1. Patients ≥18 years old and ≤70 years old;
2. Plasma of the participant can be obtained;
3. Willing to sign the informed consent;
4. 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;

Exclusion Criteria

In any of the following situations, subjects should not participate in the trial:

1. Pregnant or lactating;
2. Unable to obtain the participant's plasma;
3. Patients with other types of malignant tumors diagnosed by pathology within 5 years before enrollment;
4. The patients had suspected imaging (B-ultrasound, CT, etc.) of other malignant tumors within the past 1 year after enrollment, but no pathological confirmation;
5. Received any blood product transfusion in the past 30 days;
6. Participants considered by the investigator to be inappropriate to participate in this research-type clinical trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No