Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT05806632
Status:
UNKNOWN
Last Update Posted:
2023-04-10
First Post:
2023-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2023-03-28', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological response rate', 'timeFrame': '30 months', 'description': 'The study will mainly aim to validate the accuracy of previous developed prognostic model in distinguish between risk categories and probabilities of pathological complete response (pCR) detected in patients undergoing neoadjuvant chemotherapy (NACT) and breast surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Local Cancer']}, 'descriptionModule': {'briefSummary': 'Carcinogenesis and coagulation activation are closely related processes. In a previous study of coagulation activation in stage I-IIA breast cancer patients, we developed a prognostic model that includes coagulation activation biomarkers and demonstrated efficacy to in distinguish between risk categories and survival. Here, we propose a study useful for the validation of this prognostic model in an independent cohort of 108 patients with locally advanced breast cancer and indicated for neoadjuvant chemotherapy, followed by breast surgery. Within this study population, we will validate our prognostic model for risk assessment and risk stratification with respect to the following endpoints:\n\n1. Complete pathological response rate to definitive breast surgery;\n2. Rate of thromboembolic events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stage IIB-IIIC breast cancer undergoing neoadjuvant chemotherapy (NACT), followed by breast surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with normal organ functions\n* Cytologically/histologically proven breast cancer, stage IIB-IIIC\n* Participants must not have prophylactic or therapeutic indications for anticoagulants.\n\nExclusion Criteria:\n\n* Pregnacy\n* Metastatic breast cancer\n* Previous chemotherapy, hormone therapy, radiotherapy\n* Previous malignancies or contralateral breast cancer'}, 'identificationModule': {'nctId': 'NCT05806632', 'acronym': 'ARIAS', 'briefTitle': 'Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification in Reference to Patient Important Outcomes for Locally Advanced Breast Cancer: The ARIAS Trial', 'orgStudyIdInfo': {'id': 'RS1307/20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Prognostic model', 'type': 'OTHER', 'description': 'Risk assessment and risk stratification'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Marchetti', 'role': 'CONTACT'}], 'facility': 'Policlinico Umberto I', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paola Cassano', 'role': 'CONTACT'}], 'facility': 'Policlinico Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00144', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'facility': '"Regina Elena" National Cancer Institute', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Patrizia Vici, MD', 'role': 'CONTACT', 'email': 'patrizia.vici@ifo.gov.it', 'phone': '+39 06 52665698'}, {'name': 'Maddalena Barba, MD', 'role': 'CONTACT', 'email': 'maddalena.barba@ifo.gov.it', 'phone': '+39 0652665419'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}