Clinical trial · Observational
Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer
NCT06876610CI-TRIAL-00087227recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to construct an auxiliary diagnostic model for breast cancer by methylation markers. The study will collect blood and tissue samples from participants with breast cancer and benign disease for whole-genome methylation sequencing. It will screen methylation markers and develop a methylation auxiliary diagnosis model to distinguish between breast cancer and non-cancer.
Conditions
Conditions (1)
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 Screening | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cancer Arm
- description
- Participants with breast cancer from which a tumor tissue will be collected. Participants with new diagnosis of breast cancer from which a blood sample will be collected.
- label
- Benign Diseases Arm
- description
- Participants with breast benign diseases from which a tissue will be collected. Participants with breast benign diseases from which a blood sample will be collected.
Primary outcomes (3)
- measure
- Establish DNA methylation profiles of two populations by collecting tissues and peripheral blood related to benign and malignant breast nodules.
- timeFrame
- 12 months
- measure
- Based on DNA methylation profiles, systematically evaluate the signal, noise, and complementarity of methylation biomarkers and ultimately form a set of diagnostic biomarker combinations for breast malignant nodules.
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria for All the Participants: * With confirmed pathological diagnosis and molecular subtyping results * Ability to provide a written informed consent Exclusion Criteria for Cancer Arm Participants: * Patients with a history of or currently suffering from other malignancies * Pregnant or planning to become pregnant female patients * Patients who have received cancer treatment, including surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy, before blood draw * Patients with a history of blood transfusion within the past month * Patients with a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation * Patients with persistent fever or undergoing anti-inflammatory treatment within 14 days before blood draw * Any other conditions that the researcher deems may make the patient unsuitable for inclusion in the study or may interfere with the completion of the study * Patients in poor physical condition who are not suitable for blood draw * Patients who cannot provide informed consent or refuse blood draw Exclusion Criteria for Benign Diseases Arm Participants: * History of malignancies * Current malignancies or precancerous lesions
References
Publications (0)
Data not yet available
No reference posted for this study.