Examining breath markers in women with specific breast ultrasound findings
Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade
This study is testing if certain chemicals in the breath of women with specific breast ultrasound results can help tell the difference between non-cancerous and cancerous breast conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06489158 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore volatile organic compounds (VOCs) in exhaled breath as potential biomarkers to differentiate between benign and malignant breast diseases in women with BI-RADS 4 ultrasound findings. The study will compare the accuracy of these VOC indicators against ultrasound diagnoses and pathological gold standards. Eligible participants must have a surgical treatment scheduled within one week of the VOC test and must provide informed consent. The study excludes individuals with a history of certain medical conditions or previous breast cancer diagnoses.
Who should consider this trial
Good fit: Ideal candidates for this study are women with ultrasound-confirmed BI-RADS 4a, 4b, or 4c breast lesions who are scheduled for surgical treatment.
Not a fit: Patients who have already been diagnosed with breast cancer or have a history of certain medical conditions, such as respiratory diseases or metabolic disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for distinguishing between benign and malignant breast conditions, potentially improving early diagnosis and treatment.
How similar studies have performed: While the use of VOCs as biomarkers is an emerging field, similar studies have shown promise in other cancers, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- 41 Damucang Hutong, Xicheng District — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yali Xu
- Email: 49950757@qq.com
- Phone: +86-13717761030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.