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Trial Title:
Exploring a Breast Cancer Early Screening Model Based on cfDNA
NCT ID:
NCT06016790
Condition:
Breast Cancer
Breast Fibroadenoma
Breast Hypoplasia
Conditions: Official terms:
Breast Neoplasms
Fibroadenoma
Conditions: Keywords:
cfDNA
Deep learning
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
cfDNA sequencing
Description:
Multi-omics sequencing of cfDNA in peripheral venous blood.
Arm group label:
the benign control group
Arm group label:
the cancer group
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.
Criteria for eligibility:
Study pop:
Breast cancer patients and patients with benign breast diseases.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhou
Phone:
086 13575482050
Facility:
Name:
Sir Run Run Shaw Hospital Affiliated With Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiqi Lu
Facility:
Name:
Women's Hospital School Of Medicine Zhejiang University
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhou
Facility:
Name:
Zhejiang Provincial Hospital Of Traditional Chinese Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xidong Gu
Facility:
Name:
Second Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
Chao Ni
Phone:
086 13989463951
Email:
nicaho428@zju.edu.cn
Facility:
Name:
Ningbo Medical Center Lihuili Hospital
Address:
City:
Ningbo
Zip:
315046
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinhua Ding
Start date:
May 3, 2023
Completion date:
May 2, 2024
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
OmixScience Co., Ltd.
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06016790
http://www.freenome.com/largest-clinical-study-validating-a-blood-based-colorectal-screening-test-completes-enrollment
