Breast cancer
Conditions
Interventions
Gold Standard:Gold standard of targeted therapy sensitivity: targeted therapy sensitivity was assessed by the RCB system recommended by the International Breast Collaborative Group, which requires ass
RCB-I: small amount of residual tumor
RCB-II: moderate amount of residual tumor
RCB-III: extensive residual cancer). pCR
RCB-I: small amount of tumor residue
RCB-II: moderate amount of residue
RCB-III: extensive residue). Patients with RCB-0 and RCB-I after neoadjuvant therapy had a better prognosis and a low risk of distant recurrence, defined as the target-sensitive group
RCB-II and RCB-III had a worse prognosis and a high risk of distant recurrence, defined as the target-insensitive group.
Index test:Multi temporal imaging genomics based on miRNA regulatory pathways
(1) Imaging data collection: MRI images were collected using a unified standard (DICOM format) for each case before neoadjuvant treatment, 1 cycle after treatment, mid-term, and preoperative. The MRI
(2) The pre-treatment biopsy specimen was also used for miRNA sequencing
Collect elbow vein blood samples before neoadjuvant therapy, 1 cycle after treatment, mid-term, and preoperative for circulating tumor (CT) miRNA sequencing.
(3) Clinical and pathological parameters W
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Stage II-III HER2 positive breast cancer patients confirmed by puncture biopsy; (2) Complete pathological classification and grading, TNM staging before surgery, and have undergone immunohistochemical testing (including ER, PR, HER2, Ki67) and HER2 FISH testing (for HER2+immunohistochemical patients); (3) Has not received any other treatment before neoadjuvant therapy.
Exclusion criteria
Exclusion criteria: (1) Severe illness patients who cannot cooperate with the examination; (2) There are contraindications for MRI examination; (3) On MRI images, there is a hidden cancer or a cancer lesion with a length diameter less than 1.0cm; (4) New adjuvant therapy that has not completed the standard number of cycles; (5) No surgery was performed or postoperative pathological information was obtained after neoadjuvant therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The standard MRI acquisition sequences include plain T1WI, T2WI, DWI, DCE, and MDME;Circulating tumor (ct) - miRNA;Sensitivity, specificity, accuracy, AUC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical and pathological parameters; | — |
Countries
China
Contacts
Public ContactSiyao Du
The First Hospital of China Medical University
Outcome results
None listed