Exploring a Breast Cancer Early Screening Model Based on cfDNA

Breast Cancer Clinical Trial

Official title:

Scientific Research on Exploring a Breast Cancer Early Screening Model Using cfDNA Multi-omics Liquid Biopsy Technology Based on Deep Learning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016790
• Other study ID #: ZE-OMIX-001
• Status: Recruiting
• Start date: May 3, 2023
• Est. completion date: May 2, 2024

Study information

• Verified date: October 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yanchang Li
• Phone: 086 18595444144
• Email: liyanchang[@]omixscience.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 2, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Fibroadenoma
• Breast Hypoplasia
• Breast Neoplasms
• Fibroadenoma

Intervention

Genetic:
• cfDNA sequencing
Multi-omics sequencing of cfDNA in peripheral venous blood.

Locations

Country	Name	City	State
China	Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital Affiliated With Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Women's Hospital School Of Medicine Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Provincial Hospital Of Traditional Chinese Medicine	Hangzhou	Zhejiang
China	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	OmixScience Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

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, Dracopo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the sensitivity and specificity of the early detection model for breast cancer screening		60 days
Secondary	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.	60 days

External Links

•   Freenome, a privately held biotech company, announced the completion of enrollment for PREEMPT CRC, the company's large, prospective study to validate its blood test for colorectal cancer (CRC) screening among average-risk adults.