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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06016790
Other study ID # ZE-OMIX-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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