Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer

NCT06876610 | Recruiting

• 1 other identifier: 25/071-5017
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Screening

Outcome Measures

Primary Outcomes (3)

• 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 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.

  12 months

Study Arms (2)

Cancer Arm

Participants with breast cancer from which a tumor tissue will be collected. Participants with new diagnosis of breast cancer from which a blood sample will be collected.

Benign Diseases Arm

Participants with breast benign diseases from which a tissue will be collected. Participants with breast benign diseases from which a blood sample will be collected.

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of breast cancer and benign diseases.

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Geneplus-Beijing Co. Ltd.: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 14, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-02

Locations

CN (1)