Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.

Completed

• Conditions: Oxidative Stress; Lipid Peroxidation; Inflammation; Neoplasms; Antioxidants; Lysosome Alteration
• Interventions: Diagnostic Test: Patients

• Registration Number: NCT03470857
• Lead Sponsor: Nicolaus Copernicus University

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.

Study Timeline

• Study Start: 2017-06-19
• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-20
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Patients	Oncological patients: lymphomas (Hodgkin's, DLBCL), breast and ovarian cancers, brain gliomas.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Department of Positron Emission Tomography and Molecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University; 🇵🇱 Bydgoszcz, Kujawsko Pomorskie, Poland

Department of Nuclear Medicine of Center Oncology in Bydgoszcz; 🇵🇱 Bydgoszcz, Kujawsko-Pomorskie, Poland

The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University; 🇵🇱 Bydgoszcz, Kujawsko-Pomorskie, Poland