Recruiting NCT04353557
ctDNA Monitoring in Early Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer
Overview
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.
Primary outcome measures
- Positive ctDNA detection at first post-operative timepoint [Time frame: 1 month post-surgery]
Secondary outcome measures (3)
- Positive ctDNA detection at post-operative timepoints [Time frame: 6/12/18/24/30 months]
- Association between ctDNA detection and time to recurrence [Time frame: 1 month post-surgery]
- Association between ctDNA detection and time to recurrence [Time frame: 6/12/18/24/30 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Army Medical Center of PLA, China — Chongqing
Identifiers
NCT: NCT04353557 · Geneplus2020BC01