RecruitingRecruiting
Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer
NCT06876610 · Geneplus-Beijing Co. Ltd.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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 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
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-03-15
Estimated completion: 2026-08-31
Last updated: 2025-03-14
Primary outcomes
- • 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)
Sponsor
Geneplus-Beijing Co. Ltd. · industry
With: Chinese Academy of Medical Sciences
All locations (1)
Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting
Beijing, Beijing Municipality, China