Early diagnosis and monitoring of breast cancer recurrence

Early Auxiliary Diagnosis and Postoperative Recurrence Monitoring of Breast Cancer Based on Plasma ctDNA Methylation Markers

This study is testing new blood markers to see if they can help detect breast cancer early and monitor patients for signs of recurrence after treatment.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Singlera Genomics Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05858242 on ClinicalTrials.gov

What this trial studies

This study aims to identify effective methylation markers in breast cancer and establish a detection system for early screening and diagnosis. It involves two stages: the first focuses on screening and verifying plasma ctDNA polygene methylation markers that differentiate breast cancer from non-breast cancer samples. The second stage monitors postoperative patients for recurrence risk using dynamic ctDNA methylation assessments and regular follow-ups over two years.

Who should consider this trial

Good fit: Ideal candidates include women aged 18 to 80 with newly diagnosed breast cancer or precancerous lesions, as well as healthy individuals over 50.

Not a fit: Patients with a history of previous breast cancer or other malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and monitoring of breast cancer recurrence, enhancing patient outcomes.

How similar studies have performed: Other studies have shown promise in using ctDNA methylation for cancer monitoring, suggesting potential success for this approach.

Eligibility criteria

The first stage Inclusion Criteria：

Women between the ages of 18 and 80 who are not pregnant or lactating; Meet any of the following categories:

1. Breast cancer Newly diagnosed breast cancer patients \[according to breast cancer TNM staging\]; The patient was not accepted prior to blood collection Any breast cancer antitumor related treatment, including surgery, transplantation, radiation, chemotherapy, etc.
2. precancerous lesions Dysplasia, carcinoma in situ, atypical hyperplasia, etc., no previous history of malignant tumor.
3. Benign lesions These include fibroadenoma of the breast, intraductal papilloma of the breast, cystic hyperplasia of the breast, lobulated tumors of the breast, Plasma cell mastitis.
4. Healthy people No abnormal breast, no history of malignancy within 5 years; Age 50 years or above.

Exclusion Criteria:

1. previous breast cancer;
2. A history of other cancers;
3. Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months
4. Participate in other interventional clinical researchers, pregnant or lactating women, or patients suffering from autoimmune diseases, genetic diseases, mental disorders, etc., within 3 months.
5. Patients with other diseases deemed unsuitable for inclusion by the researcher;

The second stage Inclusion Criteria：

1. Patients with definite pathological diagnosis of breast cancer who were to receive radical surgery after preoperative evaluation for initial treatment
2. Women aged between 18 and 80 who are not pregnant or lactating;
3. The radical surgery to be received includes mastectomy radical surgery, simple excision + sentinel lymph node biopsy and modified radical surgery, and on this basis, mastectomy plastic surgery, stage I reconstruction and other operations that have the same radical treatment effect and do not affect the entire standardized treatment of patients
4. Enrolled patients were newly treated breast cancer patients without prior malignant tumor history and treatment history

Exclusion Criteria:

1. Stage IV breast cancer patients, or ECOG score \> 2.
2. A history of malignant tumor or other hereditary diseases;
3. Have received organ transplantation, stem cell transplantation, bone marrow transplantation or received blood transfusion within the past month;

Where this trial is running

Beijing, Beijing

• Beijing Friendship Hospital Affiliated to Capital Medical University — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Liu Rui, Doctor — Singlera Genomics Inc.
• Study coordinator: Zhang Huiming, Doctor

Conditions Breast Cancer; ctDNA methylation; Relapse monitoring