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NCT Number: NCT06876610

Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Establish DNA methylation profiles of two populations by collecting tissues and peripheral blood related to benign and malignant breast nodules.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  3. Further develop a methylation assisted diagnostic model that can effectively distinguish between benign and malignant breast nodules.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Geneplus-Beijing Co. Ltd.

Industry

Collaborators

  • Chinese Academy of Medical Sciences

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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