Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Detect VOCs in exhaled gas.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- 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.
Primary outcome measures
- Exhaled VOC Biomarkers [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- 41 Damucang Hutong, Xicheng District — Beijing
Identifiers
NCT: NCT06489158 · PekingUMCH-BCVOC200