Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.

Sponsor

Nicolaus Copernicus University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03470857

Collaborator

(none)

450

Enrollment

Locations

48.4

Anticipated Duration (Months)

150

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Antioxidants Oxidative Stress Lipid Peroxidation Inflammation Lysosome Alteration	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 Design

Study Type:

Observational

Anticipated Enrollment :

450 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 19, 2017

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Positron Emission Tomography and Molecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University	Bydgoszcz	Kujawsko Pomorskie	Poland	85-796
2	The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University	Bydgoszcz	Kujawsko-Pomorskie	Poland	85-092
3	Department of Nuclear Medicine of Center Oncology in Bydgoszcz	Bydgoszcz	Kujawsko-Pomorskie	Poland	85-796