Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 8:30 AM
Study NCT ID:
NCT03470857
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2018-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'C566438', 'term': 'Ceroid Lipofuscinosis, Neuronal, 10'}, {'id': 'D019896', 'term': 'alpha 1-Antitrypsin Deficiency'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013352', 'term': 'Subcutaneous Emphysema'}, {'id': 'D004646', 'term': 'Emphysema'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016867', 'term': 'Immunocompromised Host'}], 'ancestors': [{'id': 'D055633', 'term': 'Immune System Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Venous blood collected from the basilic vein from the study participants into two vacuum test tubes only once (from patients during FDG PET-CT diagnosis): for full blood (K2EDTA) and blood serum (clot activator and gel separator).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2018-03-13', 'studyFirstSubmitQcDate': '2018-03-19', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Superoxide Dismutase', 'timeFrame': '1 day (Single measurement)', 'description': 'Antioxidant enzyme'}, {'measure': 'Catalase', 'timeFrame': '1 day (Single measurement)', 'description': 'Antioxidant enzyme'}, {'measure': 'Glutathione Peroxidase', 'timeFrame': '1 day (Single measurement)', 'description': 'Antioxidant enzyme'}, {'measure': 'Thiobarbituric acid reactive substances (Malondialdehyde)', 'timeFrame': '1 day (Single measurement)', 'description': 'Secondary lipid peroxidation product'}, {'measure': 'Conjugated Dienes', 'timeFrame': '1 day (Single measurement)', 'description': 'Primary lipid peroxidation product'}, {'measure': '8-iso-Prostaglandin F2alpha', 'timeFrame': '1 day (Single measurement)', 'description': 'Secondary lipid peroxidation product'}, {'measure': '4-Hydroxynonenal', 'timeFrame': '1 day (Single measurement)', 'description': 'Secondary lipid peroxidation product'}, {'measure': 'Total Antioxidant Capacity', 'timeFrame': '1 day (Single measurement)', 'description': 'Total antioxidant potential of blood serum in the participant'}, {'measure': 'Acid Phosphatase', 'timeFrame': '1 day (Single measurement)', 'description': 'Lysosomal enzyme'}, {'measure': 'Cathepsin D', 'timeFrame': '1 day (Single measurement)', 'description': 'Lysosomal enzyme'}, {'measure': 'Arylsulfatase', 'timeFrame': '1 day (Single measurement)', 'description': 'Lysosomal enzyme'}, {'measure': 'Alpha-1-Antitrypsin', 'timeFrame': '1 day (Single measurement)', 'description': 'Serine protease inhibitor'}, {'measure': 'Vitamins A and E', 'timeFrame': '1 day (Single measurement)', 'description': 'Low molecular weight antioxidants'}], 'secondaryOutcomes': [{'measure': 'FDG PET/CT scanning', 'timeFrame': '1 day (Single measurement)', 'description': 'Positron emission tomography with 2-deoxy-2-\\[fluorine-18\\]fluoro- D-glucose integrated with computed tomography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positron Emission Tomography Computed Tomography', 'Fluorodeoxyglucose F18', 'Cancer', 'Superooxide Dismutase', 'Catalase', 'Glutathione Peroxidase', 'Malondialdehyde', 'Conjugated Dienes', 'Acid Phosphatase', 'Cathepsin D', 'Alpha-1-Antitrypsin', 'Arylsulfatase', '8-iso-Prostaglandin F2alpha', '4-Hydroxynonenal', 'Total Antioxidant Capacity', 'Vitamin A', 'Vitamin E'], 'conditions': ['Neoplasms', 'Antioxidants', 'Oxidative Stress', 'Lipid Peroxidation', 'Inflammation', 'Lysosome Alteration']}, 'descriptionModule': {'briefSummary': 'The research aims to determine the parameters of oxidative stress and inflammatory processes and compare these parameters with the image obtained using positron emission tomography (PET) with 2-deoxy-2-\\[fluorine-18\\]fluoro- D-glucose (18F-FDG) integrated with computed tomography (CT) in the group of oncological patients.', 'detailedDescription': "FDG PET/CT is very sensitive imaging tool for the detection of neoplasms. Neoplasm tissue is characterized by a much higher level of metabolism than healthy tissues, therefore a 95% cases of use the method regard oncology. Fluorodeoxyglucose (FDG) is absorbed by patients' organism as glucose but it does not undergo metabolism. The increased degree of FDG accumulation in tissue means its higher metabolic activity. FDG accumulates in the tumor tissue and radiates enabling its detection but the substance has not been shown to be harmful to patient at doses used in the diagnostics.\n\nTumor formation is a multi-stage process in which the phases of initiation, promotion and progression are distinguished. Neoplastic transformation of healthy cells is associated with disturbances of the cell cycle caused by mutations of proto-oncogenes (activation of cell division) and/or suppressor genes (blocking cell division) and mutator genes (protecting the DNA against damage or its repairing) under the influence of various factors. Increasing data indicate that one of the most important factors initiating neoplasm are reactive oxygen species (ROS) and oxidative stress. Mechanisms responsible for induction of oxidative stress in cancer cells are not fully explained. It is known that they are closely related to inflammation, as well as intense cellular metabolism associated with continuous proliferation, mutations in the genetic material and dysfunctions in the mitochondrial respiratory chain.\n\nIn this study a number of markers of oxidative stress and inflammation are planned to be determined including: the activities of antioxidant and lysosomal enzymes, as well as concentrations of lipid peroxidation products and low molecular weight antioxidants. The PET/CT imaging will be performed as part of standard medical procedures related to the diagnosis and monitoring of cancer diseases at the Oncology Center in Bydgoszcz, Poland."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients of the Oncology Center in Bydgoszcz, Poland, who suffer from: lymphomas (Hodgkin's, DLBCL), breast and ovarian cancers and brain gliomas. The patients report to the Oncology Center for PET-CT diagnosis.\n\nControl group: similar age and the same sex as the patients; number: the half number of the patients.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- sign informed consent form for participation in the study\n\nExclusion Criteria:\n\n* other diseases,\n* bad feeling of the studied individual on the day of the study,\n* the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators.'}, 'identificationModule': {'nctId': 'NCT03470857', 'briefTitle': 'Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Nicolaus Copernicus University'}, 'officialTitle': 'Oxidative Stress and Inflammatory Processes in Selected Neoplasms in the Group of Oncological Patients Examined With the FDG PET/CT Method.', 'orgStudyIdInfo': {'id': 'KB 363/2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': "Oncological patients: lymphomas (Hodgkin's, DLBCL), breast and ovarian cancers, brain gliomas.", 'interventionNames': ['Diagnostic Test: Patients']}, {'label': 'Control', 'description': "The number at most half as large as the patients' group, composed of healthy people at similar age and the same sex as patients."}], 'interventions': [{'name': 'Patients', 'type': 'DIAGNOSTIC_TEST', 'description': 'The FDG PET/CT imaging will be performed as part of typical medical procedures related to the diagnosis and monitoring of cancers at the Oncology Center in Bydgoszcz, Poland', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-092', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '85-796', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Department of Nuclear Medicine of Center Oncology in Bydgoszcz', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '85-796', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Department of Positron Emission Tomography and Molecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'overallOfficials': [{'name': 'Paweł Sutkowy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no the individual participant data (IPD) sharing plan.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nicolaus Copernicus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Paweł Sutkowy', 'investigatorAffiliation': 'Nicolaus Copernicus University'}}}}