Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.
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|ClinicalTrials.gov Identifier: NCT03470857|
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment|
|Neoplasms Antioxidants Oxidative Stress Lipid Peroxidation Inflammation Lysosome Alteration||Diagnostic Test: 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.
|Study Type :||Observational|
|Estimated Enrollment :||450 participants|
|Official Title:||Oxidative Stress and Inflammatory Processes in Selected Neoplasms in the Group of Oncological Patients Examined With the FDG PET/CT Method.|
|Actual Study Start Date :||June 19, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Oncological patients: lymphomas (Hodgkin's, DLBCL), breast and ovarian cancers, brain gliomas.
Diagnostic Test: 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
The number at most half as large as the patients' group, composed of healthy people at similar age and the same sex as patients.
- Superoxide Dismutase [ Time Frame: 1 day (Single measurement) ]Antioxidant enzyme
- Catalase [ Time Frame: 1 day (Single measurement) ]Antioxidant enzyme
- Glutathione Peroxidase [ Time Frame: 1 day (Single measurement) ]Antioxidant enzyme
- Thiobarbituric acid reactive substances (Malondialdehyde) [ Time Frame: 1 day (Single measurement) ]Secondary lipid peroxidation product
- Conjugated Dienes [ Time Frame: 1 day (Single measurement) ]Primary lipid peroxidation product
- 8-iso-Prostaglandin F2alpha [ Time Frame: 1 day (Single measurement) ]Secondary lipid peroxidation product
- 4-Hydroxynonenal [ Time Frame: 1 day (Single measurement) ]Secondary lipid peroxidation product
- Total Antioxidant Capacity [ Time Frame: 1 day (Single measurement) ]Total antioxidant potential of blood serum in the participant
- Acid Phosphatase [ Time Frame: 1 day (Single measurement) ]Lysosomal enzyme
- Cathepsin D [ Time Frame: 1 day (Single measurement) ]Lysosomal enzyme
- Arylsulfatase [ Time Frame: 1 day (Single measurement) ]Lysosomal enzyme
- Alpha-1-Antitrypsin [ Time Frame: 1 day (Single measurement) ]Serine protease inhibitor
- Vitamins A and E [ Time Frame: 1 day (Single measurement) ]Low molecular weight antioxidants
- FDG PET/CT scanning [ Time Frame: 1 day (Single measurement) ]Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470857
|Contact: Paweł Sutkowy, PhDemail@example.com|
|Department of Positron Emission Tomography and Molecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University||Recruiting|
|Bydgoszcz, Kujawsko Pomorskie, Poland, 85-796|
|Contact: Bogdan Małkowski, PhD, MD +48523743430 firstname.lastname@example.org|
|The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University||Recruiting|
|Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-092|
|Contact: Paweł Sutkowy, PhD +48525853822 email@example.com|
|Department of Nuclear Medicine of Center Oncology in Bydgoszcz||Recruiting|
|Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-796|
|Contact: Jolanta Czuczejko, PhD +48523743430 firstname.lastname@example.org|
|Principal Investigator:||Paweł Sutkowy, PhD||The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University|