An observational study in Neoplasms, Antioxidants and Oxidative Stress, sponsored by Nicolaus Copernicus University. Completed at 3 sites in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Nicolaus Copernicus University · Observational
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.
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.
Tumor 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.
In 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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 83 is below the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Nicolaus Copernicus University is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Control group: similar age and the same sex as the patients; number: the half number of the patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oncological patients: lymphomas (Hodgkin's, DLBCL), breast and ovarian cancers, brain gliomas.
Diagnostic Test: Patients
The number at most half as large as the patients' group, composed of healthy people at similar age and the same sex as patients.
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
Superoxide Dismutase
Antioxidant enzyme
Time frame: 1 day (Single measurement)
Catalase
Antioxidant enzyme
Time frame: 1 day (Single measurement)
Glutathione Peroxidase
Antioxidant enzyme
Time frame: 1 day (Single measurement)
Thiobarbituric acid reactive substances (Malondialdehyde)
Secondary lipid peroxidation product
Time frame: 1 day (Single measurement)
Conjugated Dienes
Primary lipid peroxidation product
Time frame: 1 day (Single measurement)
8-iso-Prostaglandin F2alpha
Secondary lipid peroxidation product
Time frame: 1 day (Single measurement)
4-Hydroxynonenal
Secondary lipid peroxidation product
Time frame: 1 day (Single measurement)
Total Antioxidant Capacity
Total antioxidant potential of blood serum in the participant
Time frame: 1 day (Single measurement)
Acid Phosphatase
Lysosomal enzyme
Time frame: 1 day (Single measurement)
Cathepsin D
Lysosomal enzyme
Time frame: 1 day (Single measurement)
Arylsulfatase
Lysosomal enzyme
Time frame: 1 day (Single measurement)
Alpha-1-Antitrypsin
Serine protease inhibitor
Time frame: 1 day (Single measurement)
Vitamins A and E
Low molecular weight antioxidants
Time frame: 1 day (Single measurement)
FDG PET/CT scanning
Positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose integrated with computed tomography
Time frame: 1 day (Single measurement)
Plan to share: No — There is no the individual participant data (IPD) sharing plan.
No publications or documents are linked to this record.
Ran from Jun 2017 to primary completion in Jun 2021, 48 months.
Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's 48 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Nicolaus Copernicus University