Clinical trial · Observational
Exploring a Breast Cancer Early Screening Model Based on cfDNA
Scientific Research on Exploring a Breast Cancer Early Screening Model Using cfDNA Multi-omics Liquid Biopsy Technology Based on Deep Learning
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Fibroadenoma | Breast Fibroadenoma | ONTOLOGY_EXACT | 0.98 |
| Breast Hypoplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cfDNA sequencing | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- the cancer group
- description
- 503 cases of early breast cancer
- interventionNames
- Genetic: cfDNA sequencing
- label
- the benign control group
- description
- 289 cases of control group
- interventionNames
- Genetic: cfDNA sequencing
Primary outcomes (1)
- measure
- Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
- timeFrame
- 1 year from enrollment
- description
- Peripheral blood samples were collected during routine physical examinations for healthy volunteers and prior to surgery for cancer patients. The blood samples were drawn and placed into cfDNA preservation tubes (Ardent BioMed, Guangdong, China, Cat. # BY10240301). After collection, the fresh blood was subjected to an initial centrifugation at 1,600 × g for 10 minutes at 4°C, allowing the plasma supernatant to be carefully separated via pipetting. This plasma was then centrifuged again at 16,000 × g for 10 minutes at 4°C to remove any residual debris. The resulting plasma supernatant was then carefully collected and stored at -80°C. The preserved plasma samples were subsequently transported on dry ice to the central laboratory at OmixScience Research Institute (Hangzhou, China).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTMathios 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, Dracopoli NC, Maddala T, Fang KC, Hartman AR, Forde PM, Anagnostou V, Brahmer JR, Fijneman RJA, Nielsen HJ, Meijer GA, Andersen CL, Mellemgaard A, Bojesen SE, Scharpf RB, Velculescu VE. Detection and characterization of lung cancer using cell-free DNA fragmentomes. Nat Commun. 2021 Aug 20;12(1):5060. doi: 10.1038/s41467-021-24994-w. PMID 34417454