Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06681818
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2024-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2039-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-07', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation of carbon monoxide levels in exhaled breath with quantity and quality of liver regeneration', 'timeFrame': 'measurements will be taken pre, then 4 hours and 24 hours post resection', 'description': 'patients will be asked to donate exhaled breath into a smokerlyzer device'}], 'secondaryOutcomes': [{'measure': 'level of carbon monoxide in exhaled air of patients', 'timeFrame': 'measurements will be taken pre, then 4 hours and 24 hours post resection', 'description': 'patients will be asked to donate exhaled breath into a smokerlyzer device'}, {'measure': 'quantity of liver regeneration, liver volume (ml)', 'timeFrame': 'one and three months after resection', 'description': 'CT liver volumetric studies'}, {'measure': 'quality of hepatic regeneration, normalized liver function', 'timeFrame': 'one and three months post resection', 'description': 'serum protein, albumin, AST and ALT, alkaline phosphatase, and bilirubin level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatectomy'], 'conditions': ['Liver Cancer Adult', 'Liver Regeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.englewoodhealth.org/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'the investigators will pursue two specific aims: (1) to monitor the extent of heme oxygenase induction (by measuring endogenous CO production) in relationship to the extent of hepatic resection (2) to assess the production of CO in patients following liver resection and correlate these findings to the rate of liver regeneration and liver function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient plans to have partial liver resection for primary liver pathology or metastatic disease\n* Patient is able to comprehend and willing to sign the written consent form\n\nExclusion Criteria:\n\n* Patients \\< 18 years\n* Patients identified as members of a vulnerable population, except women of child bearing potential with negative pregnancy test'}, 'identificationModule': {'nctId': 'NCT06681818', 'briefTitle': 'Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Englewood Hospital and Medical Center'}, 'officialTitle': 'Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy', 'orgStudyIdInfo': {'id': 'E-24-982'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'all participants', 'description': 'all participants will provide breath samples to detect carbon monoxide levels', 'interventionNames': ['Other: carbon monoxide measurement via smokerlyzer']}], 'interventions': [{'name': 'carbon monoxide measurement via smokerlyzer', 'type': 'OTHER', 'description': 'participants in this study will provide breath samples for carbon monoxide measurements pre and post liver resection', 'armGroupLabels': ['all participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie Ketas', 'role': 'CONTACT', 'email': 'jamie.ketas@ehmchealth.org', 'phone': '2018943418'}, {'name': 'Raquel Molina', 'role': 'CONTACT', 'email': 'raquel.molina@ehmchealth.org'}], 'facility': 'Englewood Hospital', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}], 'centralContacts': [{'name': 'Jamie Ketas', 'role': 'CONTACT', 'email': 'jamie.ketas@ehmchealth.org', 'phone': '2018943418'}, {'name': 'Raquel Molina', 'role': 'CONTACT', 'email': 'raquel.molina@ehmchealth.org'}], 'overallOfficials': [{'name': 'Cherif Boutros, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Englewood Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Englewood Hospital and Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}