Clinical trial NCT06489158: Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade
Official title: Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with BI-RADs 4 breast lesions by ultrasound

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

Eligibility criteria: 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

Primary outcomes:
measure: Exhaled VOC Biomarkers
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: 41 Damucang Hutong, Xicheng District
state: Beijing
Study officials:
References: