Using blood tests to help diagnose breast cancer
Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer
This study is testing whether blood tests that look for specific markers can help doctors tell the difference between breast cancer and non-cancerous conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Geneplus-Beijing Co. Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06876610 on ClinicalTrials.gov |
What this trial studies
This study aims to develop an auxiliary diagnostic model for breast cancer by analyzing methylation markers in blood and tissue samples. Participants with confirmed breast cancer and benign conditions will provide samples for whole-genome methylation sequencing. The goal is to identify specific methylation markers that can effectively differentiate between breast cancer and non-cancerous conditions. This observational study will enhance diagnostic accuracy and potentially improve early detection of breast cancer.
Who should consider this trial
Good fit: Ideal candidates include individuals with a confirmed pathological diagnosis of breast cancer or benign breast disease who can provide informed consent.
Not a fit: Patients with a history of other malignancies or those currently undergoing cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and less invasive breast cancer diagnoses.
How similar studies have performed: While the use of methylation markers in cancer diagnostics is a growing field, this specific approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.