Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade
Recruiting · NCT06489158 · Observational (researchers observe without assigning treatment) · Lead sponsor: Peking Union Medical College Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Detect VOCs in exhaled gas
What this trial is about
1. Explore VOCs indicators that can effectively distinguish between benign and malignant breast diseases. 2. The accuracy of VOCs indicators and ultrasound 4a/4b/4c diagnosis will be compared in determining benign and malignant diseases based on pathological gold standards.
Who can take part
Age range
18 Years to 80 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Ultrasound examination within 3 months clearly indicates that breast lesions are BI-RADs4a/4b/4c
- Surgical treatment within one week after Exhaled VOC test
- informed consent form should be signed
Exclusion criteria
- Male
- Women who have been diagnosed as breast cancer by puncture
- Individuals with unclear BI-RADs level information by breast ultrasound, including but not limited to BI-RADs 4/3-4a/4a-b/4b-c
- Pregnant or lactating women
- A positive smoking history within one year
- Medical history of malignant tumor, including but not limited to breast cancer (excluding skin basal cell carcinoma)
- The past history of metabolic diseases, including diabetes, gout, etc
- Respiratory diseases that have been clearly diagnosed in the past, such as asthma and chronic obstructive pulmonary emphysema, are not suitable for participation in the study
- Previously diagnosed digestive system diseases, such as Helicobacter pylori positivity and gastric ulcers, are not suitable for participation in the study
- Combination application of drugs related to the treatment of elderly dementia
- Possible cases which researchers believe it is not suitable for this clinical research
Where it is running
1 location listed.
- 41 Damucang Hutong, Xicheng District - Beijing, Beijing Municipality, China