Breast Cancer Screening
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Chinese Academy of Medical Sciences
Geneplus-Beijing Co. Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish DNA methylation profiles of two populations by collecting tissues and peripheral blood related to benign and malignant breast nodules. | 12 months |
| 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. | 12 months |
| Further develop a methylation assisted diagnostic model that can effectively distinguish between benign and malignant breast nodules. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the contribution and performance of methylation assisted diagnostic models by integrating imaging and methylation assisted diagnostic model results, and clarify the specificity and sensitivity of integrated model diagnosis. | 12 months |
Countries
China
Outcome results
None listed