Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-08 @ 8:08 AM
Study NCT ID:
NCT06592560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asprosin in Breast Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004797', 'term': 'Enzyme-Linked Immunosorbent Assay'}], 'ancestors': [{'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007163', 'term': 'Immunosorbent Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic value of Asprosin as a biomarker in breast cancer', 'timeFrame': 'Baseline', 'description': 'Evaluation of the clinical utility of measurement of asprosin as a non invasive biomarker in the diagnosis of breast cancer'}], 'secondaryOutcomes': [{'measure': 'Diagnostic value of Asprosin as a biomarker in breast cancer', 'timeFrame': 'Baseline', 'description': 'Comparing asproin and the routine markers (CEA, CA15-3) as biomarkers for diagnosis of breast cancer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical utility of Asprosin measurement in breast cancer patients in comparison with healthy controls and patients with benign breast lesions.\n\nTo compare between Asprosin and the routine markers (CEA, CA15-3) as biomarkers for breast cancer diagnosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1: healthy controls from healthy volunteers. Group 2: patients with benign breast lesions. Group 3: breast cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nFemales aged (40 ± 20 years) who did not receive any chemotherapy or surgical treatment and they will be divided as follow:\n\nGroup 1: healthy controls from healthy volunteers. Group 2: patients with benign breast lesions. Group 3: breast cancer patients.\n\nExclusion Criteria:\n\n* 1- Female patients with any other type of malignant or benign tumors. 2- Past history of chemotherapy or surgical treatment of cancer.'}, 'identificationModule': {'nctId': 'NCT06592560', 'briefTitle': 'Asprosin in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Diagnostic Value of Asprosin As a Biomarker in Breast Cancer', 'orgStudyIdInfo': {'id': 'Asprosin'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy people', 'interventionNames': ['Device: ELISA']}, {'label': 'Patients with benign breast lesions', 'interventionNames': ['Device: ELISA']}, {'label': 'Patients with breast cancer', 'interventionNames': ['Device: ELISA']}], 'interventions': [{'name': 'ELISA', 'type': 'DEVICE', 'description': 'Specific test: Assay of asprosin marker will be measured by enzyme-linked immunosorbent assay ( ELISA).', 'armGroupLabels': ['Healthy people', 'Patients with benign breast lesions', 'Patients with breast cancer']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marina Hanna Thabet', 'role': 'CONTACT', 'email': 'hannamarina626@gmail.com', 'phone': '01007970949'}, {'name': 'Eman Mohamed Abdelrahman', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marina Hanna Thabet Ghobrial', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Marina Hanna Thabet Ghobrial', 'investigatorAffiliation': 'Assiut University'}}}}