Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Inflammation; Oxidative Stress; Antioxidants; Lipid Peroxidation; Lysosome Alteration
• Intervention / Treatment: Diagnostic test: 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.

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Poland
  • Kujawsko Pomorskie
    • Bydgoszcz, Kujawsko Pomorskie, Poland, 85-796
      • Department of Positron Emission Tomography and Molecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University
  • Kujawsko-Pomorskie
    • Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-092
      • The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University
    • Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-796
      • Department of Nuclear Medicine of Center Oncology in Bydgoszcz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; 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
Control; The number at most half as large as the patients' group, composed of healthy people at similar age and the same sex as patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superoxide Dismutase	Antioxidant enzyme	1 day (Single measurement)
Catalase	Antioxidant enzyme	1 day (Single measurement)
Glutathione Peroxidase	Antioxidant enzyme	1 day (Single measurement)
Thiobarbituric acid reactive substances (Malondialdehyde)	Secondary lipid peroxidation product	1 day (Single measurement)
Conjugated Dienes	Primary lipid peroxidation product	1 day (Single measurement)
8-iso-Prostaglandin F2alpha	Secondary lipid peroxidation product	1 day (Single measurement)
4-Hydroxynonenal	Secondary lipid peroxidation product	1 day (Single measurement)
Total Antioxidant Capacity	Total antioxidant potential of blood serum in the participant	1 day (Single measurement)
Acid Phosphatase	Lysosomal enzyme	1 day (Single measurement)
Cathepsin D	Lysosomal enzyme	1 day (Single measurement)
Arylsulfatase	Lysosomal enzyme	1 day (Single measurement)
Alpha-1-Antitrypsin	Serine protease inhibitor	1 day (Single measurement)
Vitamins A and E	Low molecular weight antioxidants	1 day (Single measurement)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FDG PET/CT scanning	Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography	1 day (Single measurement)

Collaborators and Investigators

• Sponsor: Nicolaus Copernicus University
• Investigators: Principal Investigator: Paweł Sutkowy, PhD, The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Vitamin E; Malondialdehyde; Fluorodeoxyglucose F18; Vitamin A; Positron Emission Tomography Computed Tomography; Superooxide Dismutase; Catalase; Glutathione Peroxidase; Conjugated Dienes; Acid Phosphatase; Cathepsin D; Alpha-1-Antitrypsin; Arylsulfatase; 8-iso-Prostaglandin F2alpha; 4-Hydroxynonenal; Total Antioxidant Capacity
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Inflammation
• Other Study ID Numbers: KB 363/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no the individual participant data (IPD) sharing plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No