Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-27 @ 3:25 AM
Study NCT ID:
NCT05468593
Status:
COMPLETED
Last Update Posted:
2024-07-30
First Post:
2022-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Outcomes After Hepatic Artery Infusion Pump Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2022-07-12', 'studyFirstSubmitQcDate': '2022-07-18', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'Baseline prior to surgery.', 'description': 'Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.'}, {'measure': 'Quality of Life', 'timeFrame': 'Postoperative day 2.', 'description': 'Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.'}, {'measure': 'Quality of Life', 'timeFrame': 'Postoperative day 7.', 'description': 'Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.'}, {'measure': 'Quality of Life', 'timeFrame': 'Postoperative day 14.', 'description': 'Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.'}, {'measure': 'Quality of Life', 'timeFrame': 'Postoperative day 30.', 'description': 'Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.'}, {'measure': 'Quality of Life', 'timeFrame': 'Postoperative day 60.', 'description': 'Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.'}, {'measure': 'Quality of Life', 'timeFrame': 'Postoperative day 90.', 'description': 'Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.'}, {'measure': 'Quality of Life', 'timeFrame': 'Postoperative day 120.', 'description': 'Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.'}, {'measure': 'Quality of Life', 'timeFrame': 'Postoperative day 150.', 'description': 'Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.'}, {'measure': 'Quality of Life', 'timeFrame': 'Postoperative day 180.', 'description': 'Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.'}], 'secondaryOutcomes': [{'measure': 'Time to start chemotherapy', 'timeFrame': '1 month postoperatively', 'description': 'Number of days following hepatic artery infusion pump placement until chemotherapy is started'}, {'measure': 'Surgical outcomes', 'timeFrame': '1 month postoperatively', 'description': 'Complications with hepatic artery infusion pump placement'}, {'measure': 'Surgical outcomes', 'timeFrame': '6 month postoperatively', 'description': 'Complications with hepatic artery infusion chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic Artery Infusion', 'Pump', 'Hepatic Artery Infusion Chemotherapy', 'Unresectable Colorectal Liver Metastases'], 'conditions': ['Colorectal Liver Metastases', 'Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the surgical outcomes and the quality of life (QOL) in patients undergoing hepatic artery infusion pump placement for colorectal liver metastases (CRLM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with colorectal liver metastases (CRLM) being offered Hepatic Artery Infusion Pump placement and subsequent Hepatic Artery Infusion Chemotherapy at Mayo Clinic Rochester will be evaluated to participate in this study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who receive a Hepatic Artery Infusion Pump at Mayo Clinic Rochester for liver metastases from colorectal cancer.\n* Written consent.\n\nExclusion Criteria:\n\n* Absence of written consent.\n* Systemic disease.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05468593', 'briefTitle': 'Patient Outcomes After Hepatic Artery Infusion Pump Placement', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Patient Reported Outcomes After Hepatic Artery Infusion Pump Placement', 'orgStudyIdInfo': {'id': '22-003190'}}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Cornelius Thiels, DO, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cornelius A. Thiels', 'investigatorAffiliation': 'Mayo Clinic'}}}}