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Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.

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ClinicalTrials.gov Identifier: NCT03470857
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Paweł Sutkowy, 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.

Condition or disease Intervention/treatment
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 Type : Observational
Estimated 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 : June 19, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Venous blood collected from the basilic vein from the study participants into two vacuum test tubes only once (from patients during FDG PET-CT diagnosis): for full blood (K2EDTA) and blood serum (clot activator and gel separator).


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470857


Contacts
Contact: Paweł Sutkowy, PhD +48525853822 p.sutkowy@cm.umk.pl

Locations
Poland
Department of Positron Emission Tomography and Molecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University Recruiting
Bydgoszcz, Kujawsko Pomorskie, Poland, 85-796
Contact: Bogdan Małkowski, PhD, MD    +48523743430    petidm@cm.umk.pl   
The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University Recruiting
Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-092
Contact: Paweł Sutkowy, PhD    +48525853822    p.sutkowy@cm.umk.pl   
Department of Nuclear Medicine of Center Oncology in Bydgoszcz Recruiting
Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-796
Contact: Jolanta Czuczejko, PhD    +48523743430    joczu@wp.pl   
Sponsors and Collaborators
Nicolaus Copernicus University
Investigators
Principal Investigator: Paweł Sutkowy, PhD The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University

Responsible Party: Paweł Sutkowy, Assistant professor, Nicolaus Copernicus University
ClinicalTrials.gov Identifier: NCT03470857     History of Changes
Other Study ID Numbers: KB 363/2017
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no the individual participant data (IPD) sharing plan.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paweł Sutkowy, Nicolaus Copernicus University:
Positron Emission Tomography Computed Tomography
Fluorodeoxyglucose F18
Cancer
Superooxide Dismutase
Catalase
Glutathione Peroxidase
Malondialdehyde
Conjugated Dienes
Acid Phosphatase
Cathepsin D
Alpha-1-Antitrypsin
Arylsulfatase
8-iso-Prostaglandin F2alpha
4-Hydroxynonenal
Total Antioxidant Capacity
Vitamin A
Vitamin E

Additional relevant MeSH terms:
Neoplasms
Inflammation
Pathologic Processes