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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Breast Cancer

Treatments: Diagnostic Test: Detect VOCs in exhaled gas

Study type: Observational

Funder types: Other

Identifiers

NCT06489158

PekingUMCH-BCVOC200

Details and patient eligibility

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.

Full 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

Enrollment: 168 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

168 participants in 2 patient groups

Benign breast disease

Description:

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.

Treatment:

Diagnostic Test: Detect VOCs in exhaled gas

Breast Cancer

Description:

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.

Treatment:

Diagnostic Test: Detect VOCs in exhaled gas