Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489158
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Explore VOCs indicators that can effectively distinguish between benign and malignant breast diseases
2 The accuracy of VOCs indicators and ultrasound 4a4b4c diagnosis will be compared in determining benign and malignant diseases based on pathological gold standards
2 The accuracy of VOCs indicators and ultrasound 4a4b4c 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-RADs4a4b4c 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 43-4a4a-b4b-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
Ultrasound examination within 3 months clearly indicates that breast lesions are BI-RADs4a4b4c 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 43-4a4a-b4b-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None