RecruitingNCT06876610

Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer


Sponsor

Geneplus-Beijing Co. Ltd.

Enrollment

200 participants

Start Date

Mar 15, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 75 Years

Inclusion Criteria2

  • With confirmed pathological diagnosis and molecular subtyping results
  • Ability to provide a written informed consent

Exclusion Criteria11

  • 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
  • History of malignancies
  • Current malignancies or precancerous lesions

Locations(1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06876610


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