RecruitingNCT04353557
ctDNA Monitoring in Early Breast Cancer
Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer
Sponsor
Geneplus-Beijing Co. Ltd.
Enrollment
200 participants
Start Date
Nov 29, 2019
Study Type
OBSERVATIONAL
Conditions
Summary
This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria7
- Patients aged 18 to 80 years old
- Histologically proven primary breast cancer with clinical stage I-III
- Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated).
- Expected to achieve R0 resection.
- Estimated lifetime is more than 3 months.
- Signed Informed Consent Form
- Consent to provide research blood samples.
Exclusion Criteria4
- Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5.
- Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5.
- Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ.
- Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04353557
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