Clinical trial NCT03470857: Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.
Official title: Oxidative Stress and Inflammatory Processes in Selected Neoplasms in the Group of Oncological Patients Examined With the FDG PET/CT Method.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Antioxidants
Oxidative Stress
Lipid Peroxidation
Inflammation
Lysosome Alteration
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
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

- sign informed consent form for participation in the study

Exclusion Criteria:

* other diseases,
* bad feeling of the studied individual on the day of the study,
* the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators.

Primary outcomes:
measure: Superoxide Dismutase
timeFrame: 1 day (Single measurement)
measure: Catalase
timeFrame: 1 day (Single measurement)
measure: Glutathione Peroxidase
timeFrame: 1 day (Single measurement)
measure: Thiobarbituric acid reactive substances (Malondialdehyde)
timeFrame: 1 day (Single measurement)
measure: Conjugated Dienes
timeFrame: 1 day (Single measurement)
measure: 8-iso-Prostaglandin F2alpha
timeFrame: 1 day (Single measurement)
measure: 4-Hydroxynonenal
timeFrame: 1 day (Single measurement)
measure: Total Antioxidant Capacity
timeFrame: 1 day (Single measurement)
measure: Acid Phosphatase
timeFrame: 1 day (Single measurement)
measure: Cathepsin D
timeFrame: 1 day (Single measurement)
measure: Arylsulfatase
timeFrame: 1 day (Single measurement)
measure: Alpha-1-Antitrypsin
timeFrame: 1 day (Single measurement)
measure: Vitamins A and E
timeFrame: 1 day (Single measurement)
Secondary outcomes:
measure: FDG PET/CT scanning
timeFrame: 1 day (Single measurement)
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Department of Positron Emission Tomography and Molecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University
state: Kujawsko Pomorskie
city: Bydgoszcz
country: Poland
facility: The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University
state: Kujawsko-Pomorskie
city: Bydgoszcz
country: Poland
facility: Department of Nuclear Medicine of Center Oncology in Bydgoszcz
state: Kujawsko-Pomorskie
Study officials:
affiliation: The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University
name: Paweł Sutkowy, PhD
role: PRINCIPAL_INVESTIGATOR
References: