Breast Cancer Clinical Trial
Official title:
Prospective Study on the Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
Breast cancer is the most common malignant tumor in women worldwide,and there exist a large part of patients need to receive neoadjuvant chemotherapy(NAC) before the curative surgery.Circulating tumor DNA(ctDNA) is the circulating free DNA in the blood that originates from cancers,and it can be detected by modern technologies in plasma.In this prospective study,investigators aim to observe the correlation between tumor response to neoadjuvant chemotherapy and ctDNA.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | September 20, 2019 |
Est. primary completion date | September 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Female patients undergoing neoadjuvant chemotherapy - Age: 18-70 yrs - Any menopausal status - Any hormone receptor status - Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy): - Locally advanced tumor - Patients who received 6 to 8 cycles of neoadjuvant chemotherapy. Exclusion Criteria: - Failed to retain blood sample before NAC - Lost more than 2 blood samples during NAC |
Country | Name | City | State |
---|---|---|---|
China | Shandong Cancer Hospital and Institute | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Zhiyong Yu |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | dynamic changes of plasma ctDNA mutant copies by a panel of 363 cancer-related genes | To assess the changes of ctDNA mutant copies during the process of our observation,and to find out the relationship between ctDNA and tumor response to neoadjuvant chemotherapy | From patients recruited into the research until the surgury complete ,assessed up to 26 weeks. | |
Secondary | disease free survival after surgery | To observe the duration from the end of curative surgery to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year. | Up to 5 years |
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