Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-03-03 @ 1:44 PM
Study NCT ID:
NCT06469606
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Female Patients' Mammographic Texture Features
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2038-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mammographic texture features', 'timeFrame': 'Through study completion, an average of 5 year', 'description': 'Aim: to evaluate how imaging parameters affect the mammographic texture features'}], 'secondaryOutcomes': [{'measure': 'Biological features', 'timeFrame': 'through study completion, an average of 10 year', 'description': 'Aim: To evaluate whether there is an interplay between mammographic texture feature parameters and pathological and biological features (e.g., breast cancer biomarkers)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Artificial Intelligence', 'Mammography']}, 'descriptionModule': {'briefSummary': 'Mammography is the most common method for breast imaging, and it provides information for model building and analysis. Radiomics applied to mammography has the potential to revolutionize clinical decision-making by providing valuable insights into risk assessment and disease detection. Despite this, the influence of imaging parameters and clinical and biological factors on radiological texture features remains poorly understood. There is a pressing need to overcome the obstacle of system-inherent effects on mammographic images to facilitate the translation of radiological texture features into routine clinical practice by enabling reliable and robust AI-based or AI-aided decision-making. Furthermore, understanding the relationship between imaging parameters, textural features, and clinical and biological information supports the clinical use of AI. The objective of this study is to evaluate AI methods for clinical practice and to study how it relates to clinical factors and biological features.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidate is a biological female aged 18 years or above;\n* Candidate is willing and able to give informed consent and gives their written consent for the participation in the study;\n* There is a clinical indication for a uni- or bilateral mastectomy\n\nExclusion Criteria:\n\n* Candidate lacks the capacity to provide informed consent;\n* Candidate has breast implants'}, 'identificationModule': {'nctId': 'NCT06469606', 'acronym': 'COMPRESS', 'briefTitle': "Study on Female Patients' Mammographic Texture Features", 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': "A Cohort Study on feMale Patients' mammogRaphic texturE featureS: the COMPRESS Trial", 'orgStudyIdInfo': {'id': 'R23077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participant diagnosed with breast cancer', 'description': 'Participants diagnosed with breast cancer who will undergo a mastectomy operation', 'interventionNames': ['Device: AI tool']}, {'type': 'EXPERIMENTAL', 'label': 'Participant not diagnosed with breast cancer', 'description': 'Participants who will undergo a mastectomy operation for a non-breast cancer related clinical indication', 'interventionNames': ['Device: AI tool']}], 'interventions': [{'name': 'AI tool', 'type': 'DEVICE', 'description': 'Both the arms will undergo the use of "AI tool" developed in the group. The tool will be trained to detect outcomes.', 'armGroupLabels': ['Participant diagnosed with breast cancer', 'Participant not diagnosed with breast cancer']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Otso Arponen, MD, PhD', 'role': 'CONTACT', 'email': 'otso.arponen@tuni.fi', 'phone': '+3583311611'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University', 'class': 'OTHER'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'University of Eastern Finland', 'class': 'OTHER'}, {'name': 'University of Turku', 'class': 'OTHER'}, {'name': 'University of Oulu', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}