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Completed

NCT Number: NCT03470857

Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nuclear Medicine of Center Oncology in Bydgoszcz, Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patients

Diagnostic Test

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

Primary outcomes

  1. Superoxide Dismutase

    Time frame: 1 day (Single measurement)

    Antioxidant enzyme

  2. Catalase

    Time frame: 1 day (Single measurement)

    Antioxidant enzyme

  3. Glutathione Peroxidase

    Time frame: 1 day (Single measurement)

    Antioxidant enzyme

  4. Thiobarbituric acid reactive substances (Malondialdehyde)

    Time frame: 1 day (Single measurement)

    Secondary lipid peroxidation product

  5. Conjugated Dienes

    Time frame: 1 day (Single measurement)

    Primary lipid peroxidation product

  6. 8-iso-Prostaglandin F2alpha

    Time frame: 1 day (Single measurement)

    Secondary lipid peroxidation product

  7. 4-Hydroxynonenal

    Time frame: 1 day (Single measurement)

    Secondary lipid peroxidation product

  8. Total Antioxidant Capacity

    Time frame: 1 day (Single measurement)

    Total antioxidant potential of blood serum in the participant

  9. Acid Phosphatase

    Time frame: 1 day (Single measurement)

    Lysosomal enzyme

  10. Cathepsin D

    Time frame: 1 day (Single measurement)

    Lysosomal enzyme

  11. Arylsulfatase

    Time frame: 1 day (Single measurement)

    Lysosomal enzyme

  12. Alpha-1-Antitrypsin

    Time frame: 1 day (Single measurement)

    Serine protease inhibitor

  13. Vitamins A and E

    Time frame: 1 day (Single measurement)

    Low molecular weight antioxidants

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nicolaus Copernicus University

Other

Registry information

Official study title

Oxidative Stress and Inflammatory Processes in Selected Neoplasms in the Group of Oncological Patients Examined With the FDG PET/CT Method.

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2018
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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