Actively Recruiting
Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer
Led by Geneplus-Beijing Co. Ltd. · Updated on 2025-03-14
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Geneplus-Beijing Co. Ltd.
Lead Sponsor
C
Chinese Academy of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are developing a diagnostic model to help distinguish breast cancer from benign breast diseases by studying methylation markers in blood and tissue samples. This observational study focuses on collecting samples from participants diagnosed with either breast cancer or benign breast conditions to analyze whole-genome methylation patterns. The goal is to find specific methylation markers that can assist in diagnosing breast nodules more accurately. The study involves two groups: one with participants having breast cancer and another with participants having benign breast diseases. Blood and tumor tissue samples will be collected from the cancer group, while blood and tissue samples will be collected from the benign group. These samples will undergo whole-genome methylation sequencing to identify diagnostic markers and develop a model that can differentiate malignant from benign breast nodules. Participants will provide tissue and blood samples, and their molecular subtyping results will be confirmed. Researchers will examine DNA methylation profiles over 12 months, evaluating the performance of methylation markers and integrating them with imaging results. The study aims to create a combined diagnostic model with high specificity and sensitivity. The total study duration for each participant is 12 months, during which safety and study completion will be monitored.
CONDITIONS
Brief Title
Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed pathological diagnosis and molecular subtyping results
- Ability to provide written informed consent
You will not qualify if you...
- History of or current other malignancies (Cancer Arm)
- Pregnant or planning to become pregnant (Cancer Arm)
- Received cancer treatment before blood draw (Cancer Arm)
- History of blood transfusion within past month (Cancer Arm)
- History of allogeneic organ or stem cell transplantation (Cancer Arm)
- Persistent fever or anti-inflammatory treatment within 14 days before blood draw (Cancer Arm)
- Any condition interfering with study completion or blood draw suitability (Cancer Arm)
- Unable or unwilling to provide informed consent or blood sample (Cancer Arm)
- History of malignancies (Benign Diseases Arm)
- Current malignancies or precancerous lesions (Benign Diseases Arm)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants provide tissue and blood samples related to benign or malignant breast nodules for DNA methylation profiling.
1 to 2 visits depending on sample type
Duration - Up to 12 months
Participants are observed as DNA methylation profiles are analyzed to develop and evaluate diagnostic models for breast nodules.
Additional assessments may occur depending on cohort assignment
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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