Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-10 @ 5:55 PM
Study NCT ID:
NCT06489158
Status:
RECRUITING
Last Update Posted:
2024-09-20
First Post:
2024-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Exhaled samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2024-06-28', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '1. Explore VOCs indicators that can effectively distinguish between benign and malignant breast diseases.\n2. 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.', 'detailedDescription': 'Inclusion Criteria:\n\nUltrasound 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\n\nExclusion Criteria:\n\nMale 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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients with BI-RADs 4 breast lesions by ultrasound', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ultrasound examination within 3 months clearly indicates that breast lesions are BI-RADs4a/4b/4c\n* Surgical treatment within one week after Exhaled VOC test\n* informed consent form should be signed\n\nExclusion Criteria:\n\n* Male\n* Women who have been diagnosed as breast cancer by puncture\n* Individuals with unclear BI-RADs level information by breast ultrasound, including but not limited to BI-RADs 4/3-4a/4a-b/4b-c\n* Pregnant or lactating women\n* A positive smoking history within one year\n* Medical history of malignant tumor, including but not limited to breast cancer (excluding skin basal cell carcinoma)\n* The past history of metabolic diseases, including diabetes, gout, etc\n* 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\n* Previously diagnosed digestive system diseases, such as Helicobacter pylori positivity and gastric ulcers, are not suitable for participation in the study\n* Combination application of drugs related to the treatment of elderly dementia\n* Possible cases which researchers believe it is not suitable for this clinical research'}, 'identificationModule': {'nctId': 'NCT06489158', 'briefTitle': 'Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade', 'orgStudyIdInfo': {'id': 'PekingUMCH-BCVOC200'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Detect VOCs in exhaled gas', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Benign breast disease', 'Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Ya Xu, PhD', 'role': 'CONTACT', 'email': 'xuyali@pumch.cn', 'phone': '86-13717761030'}], 'facility': '41 Damucang Hutong, Xicheng District', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yali Xu', 'role': 'CONTACT', 'email': '49950757@qq.com', 'phone': '+86-13717761030'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}