Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-28 @ 4:17 AM
Study NCT ID:
NCT06738459
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Retrospective Integrative Study for Metastatic Lymph Nodes 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2024-12-12', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of detecting lymph node involvement using multiparametric MRI, clinical characteristics, and laboratory data, and to compare it to the accuracy of detecting lymph node involvement using MRI alone', 'timeFrame': 'up to 2 years', 'description': 'Sensitivity, specificity, positive predictive value, and negative predictive value of the integrative model will be calculated to evaluate the diagnostic performance of the model.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the changes in lymph node involvement over time', 'timeFrame': 'up to 2 years', 'description': 'The effects of neoadjuvant therapy will be estimated as the difference in the rate of lymph node involvement before and after neoadjuvant therapy, with corresponding 95% confidence intervals.'}, {'measure': 'Evaluate the association between changes in lymph node involvement and overall survival', 'timeFrame': 'up to 2 years', 'description': 'Association between changes in lymph node involvement and overall survival (OS) will be reported as Hazard Ratio and relative 95% Confidence Interval (95% CI) OS will be calculated from neoajuvant treatment start to death or end of follow up whichever came first'}, {'measure': 'Evaluate the association between changes in lymph node involvement and progression free survival (PFS)', 'timeFrame': 'up to 2 years', 'description': 'Association between changes in lymph node involvement and overall survival (PFS) will be reported as Hazard Ratio and relative 95% Confidence Interval (95% CI) PFS will be calculated from neoajuvant treatment start to progression, death or end of follow up whichever came first'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Accurate assessment of axillary lymph nodes in patients with breast cancer is essential for prognosis and treatment planning. Staging and surgical management have evolved from axillary lymph node dissection to sentinel lymph node biopsy to minimize morbidity. However, sentinel lymph node biopsy has non-negligible morbidity, and more than 70% of biopsies are negative, calling into question its routine use. Magnetic resonance imaging (MRI) can be used to detect and stage lymph node metastases in situ, but its sensitivity and specificity are moderate to poor. Few studies have employed artificial intelligence to detect lymph node metastases on MRI images, and none have used an integrative multidata approach (IMA), defined as modeling the combination of clinical and laboratory data with multiparametric MRI.\n\nThe primary objective of this retrospective observational study is to improve the accuracy of detecting lymph node involvement in breast cancer using IMA. The secondary objective is to allow longitudinal monitoring of the effects of neoadjuvant therapy on lymph node involvement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of patients with breast cancer who underwent MRI and biopsy or surgery of axillary lymph nodes as part of their diagnosis and treatment at the involved centers.\n\nPatients of all genders, ages, and stages I-III of breast cancer will be included in the study. Patients with incomplete data or whose MRI images were of insufficient quality for analysis will be excluded.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with breast cancer who underwent MRI and biopsy or surgery of axillary lymph nodes as part of their diagnosis and treatment\n* Patients of all genders, ages, and stage I-III of breast cancer\n* Patients who underwent neoadjuvant therapy and have longitudinal imaging data available for analysis (for secondary outcome analysis)\n\nExclusion Criteria:\n\n* Patients whose MRI images were of insufficient quality for analysis\n* Patients who had a previous history of breast cancer\n* Patients with a history of axillary surgery or lymph node dissection prior to the current diagnosis of breast cancer\n* Patients who received neoadjuvant therapy at another institution'}, 'identificationModule': {'nctId': 'NCT06738459', 'acronym': 'PRISM', 'briefTitle': 'Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centro di Riferimento Oncologico - Aviano'}, 'officialTitle': 'Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer', 'orgStudyIdInfo': {'id': 'CRO-2024-049'}}, 'contactsLocationsModule': {'locations': [{'zip': '9500', 'city': 'Villach', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Thomas Kau', 'role': 'CONTACT', 'email': 'Thomas.Kau@kabeg.at'}], 'facility': 'Landeskrankenhaus Villach', 'geoPoint': {'lat': 46.61028, 'lon': 13.85583}}, {'zip': '9020', 'city': 'Austria', 'state': 'Austria', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giacomo Dal Col', 'role': 'CONTACT', 'email': 'giacomo.dacol@fraunhofer.at'}], 'facility': 'KI4LIFE, Fraunhofer Austria Research'}, {'zip': '9500', 'city': 'Villach', 'state': 'Austria', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Bernhard Petrisch', 'role': 'CONTACT', 'email': 'Bernhard.Petritsch@kabeg.at'}], 'facility': 'Klinikum Klagenfurt am Wörthersee Klagenfurt am Wörthersee'}, {'zip': '33081', 'city': 'Aviano', 'state': 'Pordenone', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Del Ben, PhD', 'role': 'CONTACT', 'email': 'fabio.delben@cro.it', 'phone': '0434 659101'}], 'facility': 'Centro di Riferimento Oncologico', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}], 'centralContacts': [{'name': 'Fabio Del Ben, PhD', 'role': 'CONTACT', 'email': 'fabio.delben@cro.it', 'phone': '0434659101'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro di Riferimento Oncologico - Aviano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}