Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women With Breast Ultrasound BI-RADS 4 Grade
- Conditions
- Breast Cancer
- Interventions
- Diagnostic Test: Detect VOCs in exhaled gas
- Registration Number
- NCT06489158
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 168
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Benign breast disease Detect VOCs in exhaled gas 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. Breast Cancer Detect VOCs in exhaled gas 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.
- Primary Outcome Measures
Name Time Method Exhaled VOC Biomarkers 1 year The relationship between exhaled VOC and breast cancer grading will be studied. 168 patients with With Breast Ultrasound BI-RADS 4 Grade were enrolled. Exhale gas was collected and tested using mass spectrometer. Exhaled VOC biomarkers characteristics in admitted women with breast ultrasound BI-RADS 4 grade will be investigated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
41 Damucang Hutong, Xicheng District
🇨🇳Beijing, Beijing, China