Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470857
• Other study ID #: KB 363/2017
• Status: Completed
• Start date: June 19, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2022
• Source: Nicolaus Copernicus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antioxidants
• Inflammation
• Lipid Peroxidation
• Lysosome Alteration
• Neoplasms
• Oxidative Stress

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Nuclear Medicine of Center Oncology in Bydgoszcz	Bydgoszcz	Kujawsko-Pomorskie
Poland	Department of Positron Emission Tomography and Molecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University	Bydgoszcz	Kujawsko Pomorskie
Poland	The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University	Bydgoszcz	Kujawsko-Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Nicolaus Copernicus University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superoxide Dismutase	Antioxidant enzyme	1 day (Single measurement)
Primary	Catalase	Antioxidant enzyme	1 day (Single measurement)
Primary	Glutathione Peroxidase	Antioxidant enzyme	1 day (Single measurement)
Primary	Thiobarbituric acid reactive substances (Malondialdehyde)	Secondary lipid peroxidation product	1 day (Single measurement)
Primary	Conjugated Dienes	Primary lipid peroxidation product	1 day (Single measurement)
Primary	8-iso-Prostaglandin F2alpha	Secondary lipid peroxidation product	1 day (Single measurement)
Primary	4-Hydroxynonenal	Secondary lipid peroxidation product	1 day (Single measurement)
Primary	Total Antioxidant Capacity	Total antioxidant potential of blood serum in the participant	1 day (Single measurement)
Primary	Acid Phosphatase	Lysosomal enzyme	1 day (Single measurement)
Primary	Cathepsin D	Lysosomal enzyme	1 day (Single measurement)
Primary	Arylsulfatase	Lysosomal enzyme	1 day (Single measurement)
Primary	Alpha-1-Antitrypsin	Serine protease inhibitor	1 day (Single measurement)
Primary	Vitamins A and E	Low molecular weight antioxidants	1 day (Single measurement)
Secondary	FDG PET/CT scanning	Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography	1 day (Single measurement)