Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer

Last updated: March 12, 2025
Sponsor: Geneplus-Beijing Co. Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06876610
25/071-5017
  • Ages 30-75
  • All Genders

Study 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 Criteria

Inclusion

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

Study Design

Total Participants: 200
Study Start date:
March 15, 2025
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.