Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 5:31 PM
Study NCT ID:
NCT06796634
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cold Atmospheric Plasma (CAP) on Peritoneal Tumor Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- Histology:', 'timeFrame': '1 year', 'description': 'Following resection, FFPE sections will be assessed morphologically, particularly for the extent of tumor necrosis using haematoxylin and eosin staining. IHC staining will be performed to investigate mechanisms of autophagia (p62 and LC3B), apoptosis (cleaved caspase 3) and proliferation (ki67).\n\n* Extent of tumor necrosis: morphological assessment\n* Proliferation: Ki67 via MIB1\n* Autophagia: p62 or LC3B\n* Apoptosis: Caspase 3 antibodies'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cold Atmospheric Plasma (CAP)', 'J-Plasma', 'Peritoneal Tumor']}, 'descriptionModule': {'briefSummary': 'There are to date no studies available that have examined the effects of CAP on tumor tissue in patients. The aim of this study is to investigate these effects in patients undergoing surgery for peritoneal metastases. Tumor nodules will be treated with different durations and intensities of CAP before being surgically removed. The resected nodules will be analyzed for tumor vitality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origin. Potential cancer types include ovarian cancer, colorectal cancer, and malignant peritoneal mesothelioma\n* Written informed consent\n* Age ≥ 18 years.'}, 'identificationModule': {'nctId': 'NCT06796634', 'briefTitle': 'Effects of Cold Atmospheric Plasma (CAP) on Peritoneal Tumor Tissue', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Effects of Cold Atmospheric Plasma (CAP) on Peritoneal Tumor Tissue', 'orgStudyIdInfo': {'id': 'ONZ-2024-0090'}, 'secondaryIdInfos': [{'id': 'B6702024000142', 'type': 'OTHER', 'domain': 'University Hospital Ghent'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origi', 'description': '* Surgery and application of CAP: at the start of surgery, an inventory is made of suitable tumor nodules that will be planned for resection. Nodules should have a maximal size of 2-3 mm, since it is unlikely that bigger lesions can be adequately treated with CAP.\n* Selected tumor nodules will be treated with the J-plasma device at the standard settings (Helium gas flow of 4 l/min, coagulation and cutting intensity at 35). The distance between the tip of the device and the tissue will be approx. 10 mm. Using a timer and footswitch, nodules will be treated at different power settings and durations:\n\n * 15 W, 30W, or 45W\n * 2, 5, or 10 seconds.\n* The treated nodules will be resected at least 30 minutes after plasma treatment, and the exact timing will be documented. The samples are split in half: one half is fixed in formalin for histology and immune histochemistry, and the other half is immediately processed for live/death staining using flow cytometry.', 'interventionNames': ['Device: J-plasma']}], 'interventions': [{'name': 'J-plasma', 'type': 'DEVICE', 'description': '* Surgery and application of CAP: at the start of surgery, an inventory is made of suitable tumor nodules that will be planned for resection. Nodules should have a maximal size of 2-3 mm, since it is unlikely that bigger lesions can be adequately treated with CAP.\n* Selected tumor nodules will be treated with the J-plasma device at the standard settings (Helium gas flow of 4 l/min, coagulation and cutting intensity at 35). The distance between the tip of the device and the tissue will be approx. 10 mm. Using a timer and footswitch, nodules will be treated at different power settings and durations:\n\n * 15 W, 30W, or 45W\n * 2, 5, or 10 seconds.\n* The treated nodules will be resected at least 30 minutes after plasma treatment, and the exact timing will be documented. The samples are split in half: one half is fixed in formalin for histology and immune histochemistry, and the other half is immediately processed for live/death staining using flow cytometry.', 'armGroupLabels': ['Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origi']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East-Flanders', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Wim Ceelen, MD, PhD, Prof', 'role': 'CONTACT', 'email': 'wim.ceelen@ugent.be', 'phone': '+3293326251'}, {'name': 'Sarah Cosyns', 'role': 'CONTACT', 'email': 'sarah.cosyns@ugent.be'}], 'facility': 'UZ Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Wim Ceelen, professor', 'role': 'CONTACT', 'email': 'wim.ceelen@ugent.be', 'phone': '+3293326251'}, {'name': 'Sarah Cosyns, doctor', 'role': 'CONTACT', 'email': 'sarah.cosyns@ugent.be', 'phone': '+3293321562'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}