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NCT Number: NCT06489158

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

41 Damucang Hutong, Xicheng District

Beijing, Beijing Municipality, 100032, China

Location status: Recruiting

Location contact

Li Ya Xu, PhD

CONTACT

[email protected]

86-13717761030

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Detect VOCs in exhaled gas

Diagnostic Test

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 outcomes

  1. Exhaled VOC Biomarkers

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yali Xu

CONTACT

[email protected]

+86-13717761030

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 5, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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