Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Detect VOCs in exhaled gas

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

• Study Type: Observational
• Enrollment (Estimated): 168

Contacts and Locations

• Study Contact: Name: Yali Xu; Phone Number: +86-13717761030; Email: 49950757@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Recruiting
      • 41 Damucang Hutong, Xicheng District
      • Contact: Li Ya Xu, PhD; Phone Number: 86-13717761030; Email: xuyali@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female patients with BI-RADs 4 breast lesions by ultrasound

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Benign breast disease; 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.	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.
Breast Cancer; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled VOC Biomarkers	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.	1 year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 9, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PekingUMCH-BCVOC200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No