Clinical trial · Observational
Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade
NCT06489158CI-TRIAL-00080934recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Detect VOCs in exhaled gas | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Diagnostic Test: Detect VOCs in exhaled gas
- label
- 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.
- interventionNames
- Diagnostic Test: Detect VOCs in exhaled gas
Primary outcomes (1)
- measure
- Exhaled VOC Biomarkers
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.