Breast Cancer Female, Diagnoses Disease
Conditions
Brief summary
This study proposed to construct an ultrasound-based diagnostic model for Differentiating Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and prospective part, which are designed for model construction and independent validation, respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the efficacy of the model for identifying malignant breast lesion from benign lesion, and finally promote the application of this diagnostic model in more clinics.
Interventions
None listed
Sponsors
Peking University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* female * with single breast lesion(maximum diameter\>0.8 cm) * agree to receive follow-up in six months and take the second breast ultrasound six month after the first breast ultrasound, if a benign diagnosis is achieved at the first ultrasound * sign the informed consent
Exclusion criteria
* lost to follow-up * failed to take the second breast ultrasound six month after the first breast ultrasound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| breast biopsy proved malignant or benign lesion | between breast ultrasound and biopsy(one week) | for patients regarded as malignant by the breast ultrasound, breast biopsy results are used as reference test, which determines the breast lesion is malignant or benign |
| two breast ultrasound identified benign lesion | between first detection of breast lesion and the second ultrasound(six month) | for patients regarded as benign by the breast ultrasound, they will receive a second breast ultrasound after six month(this is regular examination for patients with first detected breast lesion). If the second ultrasound indicates benign, the lesion will be regarded as benign |
Countries
China
Outcome results
None listed