Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer
Recruiting · NCT06876610 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
30 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences - Beijing, Beijing Municipality, China