Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-09 @ 7:00 AM
Study NCT ID:
NCT06902935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2025-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-04-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2025-02-16', 'studyFirstSubmitQcDate': '2025-03-24', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tongue appearance collection (overall tongue color)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'pale white, pale purple, light red, dark red, dark purple'}, {'measure': 'Tongue appearance collection (overall tongue coating color)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'white, yellow, no tongue coating'}, {'measure': 'Tongue appearance collection (thickness of the tongue coating)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Thin tongue coating, thick tongue coating, scanty tongue coating or no tongue coating'}, {'measure': 'Pulse condition collection (pulse strength)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'forceful, moderate, weak'}, {'measure': 'Pulse condition collection (pulse rhythm)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Regular, rapid intermittent pulse, slow intermittent pulse.'}, {'measure': 'Pulse condition collection (pulse rate)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Slow pulse, moderate pulse, normal pulse, rapid pulse, extremely rapid pulse.'}, {'measure': 'Collection of facial appearances (overall facial complexion)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Normal facial complexion, white complexion, yellow complexion, red complexion, cyan complexion, black complexion'}, {'measure': 'Collection of facial appearances (overall luster)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'With luster, without luster'}, {'measure': 'Judgment of Constitution Score', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Balanced constitution, Qi-deficiency constitution, Yang-deficiency constitution, Yin-deficiency constitution, Phlegm-dampness constitution, Damp-heat constitution, Blood-stasis constitution, Qi-stagnation constitution, Special constitution.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Screening']}, 'descriptionModule': {'briefSummary': 'Construct a breast cancer risk prediction model based on traditional Chinese medicine four diagnostic instruments and B-ultrasound images. Ensure that the key evaluation indicators of the model reach a high level through clinical verification, so as to contribute to accurate clinical diagnosis and treatment decision-making.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with breast masses who come to the clinic for medical treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients aged between 30 and 75.\n2. Patients who have a mass detected by US examination, need to undergo surgery or needle biopsy, and obtain a definite pathological result.\n3. Patients who have obtained complete identification results of tongue, pulse, face, and constitution through the traditional Chinese medicine four diagnostic instruments.\n\nExclusion Criteria:\n\n\\- 1. Patients with severe heart, liver, or kidney insufficiency, or other serious systemic diseases.\n\n2\\. Patients with a history of other malignant tumors. 3. Cases with poor - quality B - ultrasound images. 4. Cases with an unclear pathological diagnosis. 5. Patients with obvious lesions on the face, in the oral cavity, or on the tongue that may affect the measurement results.'}, 'identificationModule': {'nctId': 'NCT06902935', 'briefTitle': 'Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Taizhou Hospital'}, 'officialTitle': 'Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound', 'orgStudyIdInfo': {'id': '2025L-02-012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group', 'description': 'The patients included in the group are those whose pathological results of breast masses are malignant.', 'interventionNames': ['Diagnostic Test: Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations']}, {'label': 'Control group', 'description': 'The patients included in this group are those whose pathological results of breast masses are benign.', 'interventionNames': ['Diagnostic Test: Ultrasound diagnosis of breast cancer']}], 'interventions': [{'name': 'Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations', 'type': 'DIAGNOSTIC_TEST', 'description': "The Daosheng TCM Four-Diagnostic Instrument (DS01-A) comprehensively collects patients' TCM four-diagnostic information, covering tongue (e.g., overall color, coating color/thickness/greasiness, tooth marks, etc.), pulse (e.g., position, force, rhythm, etc.), face (e.g., overall color, luster, lip color/dryness, etc.) and constitution scores (quantifying 9 constitutions via the TCM Constitution Classification Table).", 'armGroupLabels': ['Case group']}, {'name': 'Ultrasound diagnosis of breast cancer', 'type': 'DIAGNOSTIC_TEST', 'description': 'Professional ultrasound physicians use B - ultrasound equipment of the same model to accurately collect detailed parameters of breast masses according to a standardized process. These parameters include shape (oval, round, irregular), orientation (parallel, non - parallel), margin (smooth, non - smooth, with non - smooth including blurred, angular, microlobulated, spiculated, etc.), echo pattern (anechoic, hyperechoic, complex cystic - solid echo, hypoechoic, isoechoic, heterogeneous echo), posterior echo characteristics (no change, enhancement, shadowing, mixed), calcification (microcalcification and coarse calcification within the mass, calcification outside the mass, intraductal), and vascular supply (no blood supply, internal blood supply, marginal blood supply), etc.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '318000', 'city': 'Taizhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'sunmengwei', 'role': 'CONTACT', 'email': '935275820@qq.com', 'phone': '008619804632150'}], 'facility': 'Taizhou Central Hospital (Affiliated Hospital of Taizhou University)', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}], 'centralContacts': [{'name': 'sunmengwei', 'role': 'CONTACT', 'email': '935275820@qq.com', 'phone': '008619804632150'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taizhou Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound', 'investigatorFullName': 'Sun Mengwei', 'investigatorAffiliation': 'Taizhou Hospital'}}}}