NCT06489158

Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 168 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Detect VOCs in exhaled gas	The exhaled gas of the patients should be collected within one week before surgery and be tested within 24 hours after enrollment. Then receive treatment according to the existing diagnosis and treatment process.

Timeline

• Start date: 2024-09-09
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-07-05
• Last updated: 2024-09-20

Locations

1 site across 1 country: China